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6 Predictions for the Medical Device Industry in 2019 (and how you can prepare) - Featured Image

6 Predictions for the Medical Device Industry in 2019 (and how you can prepare)

Within the past couple of years, we have experienced significant changes in the medical device indus...
FDA Plans to Modernize 510(k) - Is the Sky Falling? - Featured Image

FDA Plans to Modernize 510(k) - Is the Sky Falling?

Have you heard the news? FDA caused quite a stir when it recently announced transformative changes t...
ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body) - Featured Image

ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)

In less than four months, come March 2019, the transitional period for medical device companies to c...
FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing - Featured Image

FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

What you’ve known and believed about computer system validation, software validation, and 21 CFR Par...
Understanding the Blurred Lines Between Consumer Tech and MedTech - Featured Image

Understanding the Blurred Lines Between Consumer Tech and MedTech

Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? P...
3 Real World Document Management Horror Stories - Featured Image

3 Real World Document Management Horror Stories

In the medical device world, it’s not uncommon to get hung up on documentation. “It takes too much t...
Understanding The Differences Between Clearance vs Approval vs Granted - Featured Image

Understanding The Differences Between Clearance vs Approval vs Granted

Are you confused by regulatory terminology? Clearance. Approval. Granted.
Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring (Again)! - Featured Image

Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring (Again)!

Are you a smart, talented and ambitious individual looking to be surrounded by other elite performer...
Top 20 Medical Device Venture Capital Firms - Featured Image

Top 20 Medical Device Venture Capital Firms

If you have a great idea for a medical device or have already founded your own medical company, chan...
Streamlining The Device Marketing Authorization Process - Featured Image

Streamlining The Device Marketing Authorization Process

There are a few additional steps to take when it comes to the Medical Device Single Audit Program (M...
ISO 13485 - Ultimate Guide to Quality Management Systems (QMS) for Medical Devices - Featured Image

ISO 13485 - Ultimate Guide to Quality Management Systems (QMS) for Medical Devices

            TABLE OF CONTENTS Overview Evolution of Quality Systems General Requirements Documentati...
The New Special 510(k): What You Need To Know - Featured Image

The New Special 510(k): What You Need To Know

Have you heard the recent buzz about the FDA’s supposed new Special 510(k) Pilot Program? Is it real...
5 Myths Engineers Believe About Quality (and what is really true) - Featured Image

5 Myths Engineers Believe About Quality (and what is really true)

A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...
What's New With PMAs - Featured Image

What's New With PMAs

How do you feel about pre-market approval (PMA) for Class III medical devices?
Greenlight Guru Announces New Integration with Jira Software - Featured Image

Greenlight Guru Announces New Integration with Jira Software

Quality management software platform for medical device companies now integrates with industry-leadi...
How To Drive Executive Engagement With Quality Systems (and actually get them excited about it) - Featured Image

How To Drive Executive Engagement With Quality Systems (and actually get them excited about it)

Most Quality people I know hear the same things over and over again. "Management isn't engaged." "Ma...
How to Efficiently Raise Funds for Your Medical Device Company - Featured Image

How to Efficiently Raise Funds for Your Medical Device Company

Are you in the midst of raising funds for a device that you are trying to bring to market? It can be...
Quality vs Compliance Metrics (and what's next for FDA's Case For Quality) - Featured Image

Quality vs Compliance Metrics (and what's next for FDA's Case For Quality)

What is the FDA looking to drive forward in its Case for Quality initiative? 
7 Habits of Highly Effective True Quality Medical Device Professionals - Featured Image

7 Habits of Highly Effective True Quality Medical Device Professionals

What is true quality? How do you achieve it?
15 Reasons Why Medical Device Companies Choose Greenlight Guru - Featured Image

15 Reasons Why Medical Device Companies Choose Greenlight Guru

The medical device industry has been undergoing a major shift for the past 20 years, and now that sh...
Regulatory Tips & Strategies from a Former FDA Reviewer - Featured Image

Regulatory Tips & Strategies from a Former FDA Reviewer

What are some recent trends and observations in the medical device industry regarding regulatory aff...
FDA Aligning to ISO 13485:2016 (and Why It Matters) - Featured Image

FDA Aligning to ISO 13485:2016 (and Why It Matters)

Earlier this year, the FDA announced their intentions to change the US’s current medical device regu...
Questions to Ask Before Hiring Your QA/RA Consultant - Featured Image

Questions to Ask Before Hiring Your QA/RA Consultant

Do you work with regulatory consultants to implement a quality system or 510(k), or perform other ta...
What it Means to be Focused on Quality vs. Compliance - Featured Image

What it Means to be Focused on Quality vs. Compliance

  Would you describe your company as quality focused?
What You Need to Know About The FDA CDRH Experiential Learning Program - Featured Image

What You Need to Know About The FDA CDRH Experiential Learning Program

FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medica...
What are the Regulatory Expectations for Software as a Medical Device (SaMD)? - Featured Image

What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

  In today’s highly connected world, medical devices often include state-of-the-art software, or, th...
Latest Updates on CDRH Standards Program and IEC 60601 - Featured Image

Latest Updates on CDRH Standards Program and IEC 60601

Medical device standards seem to change and evolve all the time. Is it impossible to keep up with th...
The Importance of Good Document Management (And How To Do It) - Featured Image

The Importance of Good Document Management (And How To Do It)

The long-term success of medical device companies depends on the strength of their foundation. Good ...
Why the FDA Case for Quality Matters - Featured Image

Why the FDA Case for Quality Matters

  When I first learned about the FDA’s Case for Quality initiative, I immediately wanted to learn mo...
15 Habits of Highly Effective Regulatory Professionals - Featured Image

15 Habits of Highly Effective Regulatory Professionals

Quality and regulatory professionals in the medical device industry have to deal with a lot. In this...
21 CFR Part 11: A Complete Guide - Featured Image

21 CFR Part 11: A Complete Guide

Medical device companies that wish to sell their devices in the US and EU must implement a quality m...
Greenlight Guru Announces Advanced Document Management - Featured Image

Greenlight Guru Announces Advanced Document Management

Functionality enhances security while maintaining visibility and transparency in medical device qual...
How to Embrace Risk for Safer Devices - Featured Image

How to Embrace Risk for Safer Devices

No matter what you are working on, there are risks involved. Product development is complicated.
Scaling Regulatory and Quality with Your Company - Featured Image

Scaling Regulatory and Quality with Your Company

    Have you thought about your systems and processes related to regulatory and quality standards?
What you need to know About FDA’s Progressive Programs - Featured Image

What you need to know About FDA’s Progressive Programs

Are you familiar with FDA’s progressive programs for medical device companies? Do you know about Exp...
FDA Case for Quality Program: What, Why and How? - Featured Image

FDA Case for Quality Program: What, Why and How?

We recently launched a webinar series alongside the FDA, looking at its Case for Quality Program. Th...
What Are the Regulatory Expectations for Software as a Medical Device (SaMD)? - Featured Image

What Are the Regulatory Expectations for Software as a Medical Device (SaMD)?

These days, medical devices often include software or are standalone software. So, software as a med...
AI Explainability: What That Means and Why it Matters in Healthcare - Featured Image

AI Explainability: What That Means and Why it Matters in Healthcare

Is AI a topic we should be focused on in the medical device industry?
The Bleeding Edge: Lessons Learned for the Medical Device Industry - Featured Image

The Bleeding Edge: Lessons Learned for the Medical Device Industry

Sometimes, do things make you go, “Hhhmmmm…” Jon Speer recently watched a documentary about the medi...
AI Explainability: What that Means and Why it Matters in the Medical Device Industry - Featured Image

AI Explainability: What that Means and Why it Matters in the Medical Device Industry

Is artificial intelligence (AI) a topic that should be focused on in the medical device industry?
Why Paper-Based Quality Management Systems are No Longer an Option - Featured Image

Why Paper-Based Quality Management Systems are No Longer an Option

  It’s time to face facts: a paper-based quality management system is no longer an option.
How Human Factors Impact Your Medical Device - Featured Image

How Human Factors Impact Your Medical Device

Human factors can be a tricky topic that creates confusion, especially when it comes to medical devi...
Medical Device Companies - Top 100 in 2018 (Free Chart) - Featured Image

Medical Device Companies - Top 100 in 2018 (Free Chart)

Have you ever wondered about the biggest medical device companies in the world? Maybe you're looking...
How to Think About Quality and Regulatory as Your Company Scales - Featured Image

How to Think About Quality and Regulatory as Your Company Scales

As companies transition from being a start-up or small company to a more established business and br...
Challenging “Conventional Wisdom” in Medtech R and D - Featured Image

Challenging “Conventional Wisdom” in Medtech R and D

  The idea of “research versus development” can be highly controversial and much-debated among medic...
How to Design for Compliance with IEC60601 - Featured Image

How to Design for Compliance with IEC60601

Have you ever designed a medical device that has electrical components? Was it frustrating to go thr...
FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours - Featured Image

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...
FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You? - Featured Image

FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device R...
A Guide to Bridging User Needs Into Design Requirements - Featured Image

A Guide to Bridging User Needs Into Design Requirements

  “The answers are only as good as the questions we ask!”
Why There is a Need for Multi-Level Design Controls - Featured Image

Why There is a Need for Multi-Level Design Controls

We’ve added an exciting new update to our platform recently. The ability to manage multi-level desig...
How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage - Featured Image

How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the a...
How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years - Featured Image

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years

  Have you ever wondered what partnering with Greenlight Guru could mean for your business? We have ...
7 Questions About the European MDR Answered - Featured Image

7 Questions About the European MDR Answered

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors! - Featured Image

Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!

If there’s no use risk, then no problem! That's what most directives indicate, however, users are un...
What Medical Device Developers Should Know About Human Factors - Featured Image

What Medical Device Developers Should Know About Human Factors

Human factors can be a topic rife with confusion for medical device developers. What do they mean? W...
Tips for Running Effective Internal Quality Audits - Featured Image

Tips for Running Effective Internal Quality Audits

  How did your last internal quality audit go?
How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification - Featured Image

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

We have many different types of companies using Greenlight Guru to help them create a compliant qual...
How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification - Featured Image

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...
MYOLYN Gains 510(k) Clearance 48% Quicker Than Average Using Greenlight Guru - Featured Image

MYOLYN Gains 510(k) Clearance 48% Quicker Than Average Using Greenlight Guru

For any startup medical device company, the road to FDA 510(k) clearance can be fraught with any num...
Creating an Effective Quality Culture that Benefits Your Patients - Featured Image

Creating an Effective Quality Culture that Benefits Your Patients

  We all want medical devices that improve the quality of life for patients, right?
Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think) - Featured Image

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

When developing a new medical device, do you try to figure out the fastest and simplest way to get y...
Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1) - Featured Image

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not o...
Tips, Tricks & Best Practices for Complying with ISO 13485:2016 - Featured Image

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

When it comes to ISO 13485:2016, are you scrambling to meet requirements? Are you trying to figure o...
Greenlight Guru Announces Multi-Level Design Control Software - Featured Image

Greenlight Guru Announces Multi-Level Design Control Software

Functionality enables visibility into multiple workspaces, holistic view of design components and a ...
The Ultimate Guide To Design Controls For Medical Device Companies - Featured Image

The Ultimate Guide To Design Controls For Medical Device Companies

FDA Warning Letters and Form 483 Observations - What’s the Difference? - Featured Image

FDA Warning Letters and Form 483 Observations - What’s the Difference?

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
Helping to Prepare Biomedical Engineers Entering the Workforce - Featured Image

Helping to Prepare Biomedical Engineers Entering the Workforce

Students offer hope for our future. They will be developing products that can save our lives, or at ...
Competitive Regulatory Strategy vs. Regular Regulatory Strategy - Featured Image

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

Every medical device developer would like to take the fastest path to market, right? Sometimes the k...
How to Ensure Your Quality Management System is Effective and Benefits Patients - Featured Image

How to Ensure Your Quality Management System is Effective and Benefits Patients

When it comes to quality management compliance, would you consider yourself a box checker or a true ...
Timeline to ISO 13485:2016 (And Why You Need to Act Today) - Featured Image

Timeline to ISO 13485:2016 (And Why You Need to Act Today)

To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immedi...
7 Problems with a Paper-Based Design History File (And How to Avoid Them) - Featured Image

7 Problems with a Paper-Based Design History File (And How to Avoid Them)

If you’re using a paper-based system to manage your design history file (DHF), it can raise several ...
What You Need to Know About Risk Management and Using Post-Market Data - Featured Image

What You Need to Know About Risk Management and Using Post-Market Data

The aim for any medical device company is always to ensure that the devices they make are safe and e...
5 Most Common Problems With Your CAPA Process - Featured Image

5 Most Common Problems With Your CAPA Process

What are the most common problems with the CAPA process?
Understanding the New Requirements for QMS Software Validation in ISO 13485:2016 - Featured Image

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to t...
How to Determine the Operational Quality of a Quality System Using a Performance Assessment - Featured Image

How to Determine the Operational Quality of a Quality System Using a Performance Assessment

Are you ready for audits? ISO? FDA? Is your quality management system working the way you want it to...
Quality Management Audit or Assessment? - Featured Image

Quality Management Audit or Assessment?

What's the difference? Plenty! A typical audit only provides a sample understanding of the complianc...
Understanding the 5 Phases of Medical Device Development - Featured Image

Understanding the 5 Phases of Medical Device Development

Do you have a medical device to launch? Well I have good news for you and I have bad news for you.
What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important - Featured Image

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

Do you have a firm grasp and understanding of what substantial equivalence means in regards to the 5...
CAPA Process - Step-by-Step Instructions [Infographic] - Featured Image

CAPA Process - Step-by-Step Instructions [Infographic]

CAPA is an area that we talk about often, mainly because it’s still such a big issue for medical dev...
4 Tips for Handling Nonconformances - Featured Image

4 Tips for Handling Nonconformances

The safety and efficacy of your product rides heavily on the quality of the components that make it ...
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 - Featured Image

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

One thing that seems to be constant in the global medical device industry is change.
How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips) - Featured Image

How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips)

As your company heads back from holiday breaks, what’s happening into the New Year?
Ultimate List of Medical Device Incubators and Accelerators (50+) - Featured Image

Ultimate List of Medical Device Incubators and Accelerators (50+)

Medical startups around the United States face many of the same challenges when it comes to achievin...
Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway - Featured Image

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510...
5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare) - Featured Image

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

There is an old saying that the only thing that is constant in life is change. For the medical devic...
Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017 - Featured Image

Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017

Thanks for helping make 2017 another big and exciting year for Greenlight Guru filled with tremendou...
An Overview of What Medical Device Developers Need to Know About Human Factors - Featured Image

An Overview of What Medical Device Developers Need to Know About Human Factors

  The topic of human factors can be confusing: How does it relate to design factors and risk? Why is...
15 Steps to Getting Approval for IEC 60601-1 - Featured Image

15 Steps to Getting Approval for IEC 60601-1

  Does your company have approval for IEC 60601-1? If you produce medical electrical equipment (MEE)...
Top 30+ Medical Device Conferences You Should Be Attending in 2018 - Featured Image

Top 30+ Medical Device Conferences You Should Be Attending in 2018

If you’re looking to land your company's next big deal, keep up on the latest regulatory trends, for...
How to Integrate Complaint Handling and Risk Management - Featured Image

How to Integrate Complaint Handling and Risk Management

Did you know that complaint handling continues to be a big reason medical device companies receive 4...
Challenges with Applying Risk Management Throughout the Manufacturing Process - Featured Image

Challenges with Applying Risk Management Throughout the Manufacturing Process

Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim...
How to Streamline the Customer Complaint Handling Process - Featured Image

How to Streamline the Customer Complaint Handling Process

It can be quite nerve-wracking the very first time your medical device company receives a complaint ...
13 Steps to Creating a Risk-Based CAPA Process - Featured Image

13 Steps to Creating a Risk-Based CAPA Process

What does it mean to create a risk-based CAPA process? How should companies go about it?
Common Mistakes That Can Tank Your FDA 510(k) Submission - Featured Image

Common Mistakes That Can Tank Your FDA 510(k) Submission

Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s ...
What is Software as a Medical Device (SaMD)? - Featured Image

What is Software as a Medical Device (SaMD)?

Medical devices are a big business covering a wide range of modalities and applications. To ensure t...
Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions - Featured Image

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draf...
Here Are the 4 Types of FDA Inspections You Need to Understand - Featured Image

Here Are the 4 Types of FDA Inspections You Need to Understand

Every medical device manufacturer knows that, at some point, they should expect the FDA to arrive to...
Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes - Featured Image

Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes

The only eQMS specifically for medical device will enable companies to move beyond baseline complian...
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices - Featured Image

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

What Is This CAPA Guide About? As an experienced medical device professional who has worked with doz...
How to Prepare for the Medical Device Single Audit Program (MDSAP) - Featured Image

How to Prepare for the Medical Device Single Audit Program (MDSAP)

  How is your understanding of the Medical Device Single Audit Program (MDSAP)?
Lessons to Be Learned from Recent FDA Inspections - Featured Image

Lessons to Be Learned from Recent FDA Inspections

Something that you might find surprising is the number of medical device companies that are simply n...
How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers - Featured Image

How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers

Up until the latest revision of MEDDEV 2.7.1 was published on June 29th, 2016, clinical data provide...
Why the 510(k) Process Is So Stressful & How You Can Help Streamline It - Featured Image

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

  My guest today is Juan Carlos Serna, the co-founder of Right Submission. If you have been in the m...
Standard Conformity or Regulatory Compliance? Distinguishing the Two - Featured Image

Standard Conformity or Regulatory Compliance? Distinguishing the Two

So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...
What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

What exactly is a risk-based QMS? This is a timely topic to get into. In 2016, ISO 13485 was updated...
What You Need to Know About the 510(k) Submission Process - Featured Image

What You Need to Know About the 510(k) Submission Process

Have you ever been through the experience of having the FDA refuse to accept your 510(k)? This has h...
FDA Inspections and ISO Audits: What is the Difference? - Featured Image

FDA Inspections and ISO Audits: What is the Difference?

It’s every medical device manufacturer's favorite time… … the arrival of an FDA inspector or ISO aud...
How to Switch to eQMS Software When You’re Just Using Paper - Featured Image

How to Switch to eQMS Software When You’re Just Using Paper

  How reliable is your paper-based QMS system? This situation plays out in medical device companies ...
How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage) - Featured Image

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage)

Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must...
The Do’s and Don’ts of an FDA Inspection - Featured Image

The Do’s and Don’ts of an FDA Inspection

The FDA has arrived at your premises…
How to Translate Voice of Customer into User Needs - Featured Image

How to Translate Voice of Customer into User Needs

  How well do you do at capturing “voice of customer” and translating into user needs?
Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission - Featured Image

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

It can be confusing to know which submission type is the correct one for your particular development...
How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen) - Featured Image

How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)

  So, you haven’t completed your design controls or design history file (DHF)...
7 Common Mistakes That Can Delay Your FDA 510(k) Clearance - Featured Image

7 Common Mistakes That Can Delay Your FDA 510(k) Clearance

  The 510(k) clearance process is often met with a mix of trepidation and anticipation by medical de...
How Process Excellence Leads to Product Excellence - Featured Image

How Process Excellence Leads to Product Excellence

Today, we are talking to Mike Fisher, who is the director of product development at the Global Cente...
Debunking 8 Commonly Held CAPA Myths - Featured Image

Debunking 8 Commonly Held CAPA Myths

  CAPA (Corrective and Preventive Action) is a source of ongoing issues within medical device compan...
How to Prepare Your Design History File (DHF) for an FDA Inspection - Featured Image

How to Prepare Your Design History File (DHF) for an FDA Inspection

  So, the FDA is coming to inspect your medical device company. If you’re confident that you have ev...
Understanding FDA’s Proposed Conformity Assessment Pilot Program - Featured Image

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Today on the Global Medical Device Podcast, we’ll be talking to Mike Drues, who is a frequent guest ...
13 Common Pitfalls to Avoid During Medical Device Product Development - Featured Image

13 Common Pitfalls to Avoid During Medical Device Product Development

  Are you falling into some of the common traps that surround medical device product development?
Design Validation vs. Clinical Evaluation: What’s the Difference? - Featured Image

Design Validation vs. Clinical Evaluation: What’s the Difference?

How confident are you when it comes to design validation? Does this always involve clinical evaluati...
5 Tips for Conducting Medical Device Management Reviews - Featured Image

5 Tips for Conducting Medical Device Management Reviews

When was your last company management review? If you’re left scratching your head, it either may not...
How to Define and Decode Your Design Inputs and Design Outputs - Featured Image

How to Define and Decode Your Design Inputs and Design Outputs

We’re looking at a topic that confuses a lot of medical device developers.
Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know - Featured Image

Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know

Sometimes it feels like you need to know an entirely new language to work in the medical device fiel...
Understanding the Difference Between a General Wellness Device and a Regulated Medical Device - Featured Image

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

Today Jon Speer and Mike Drues are going to be discussing general wellness devices. Mike is the pres...
Understanding the Connection Between Complaints, CAPAs, and MDRs - Featured Image

Understanding the Connection Between Complaints, CAPAs, and MDRs

Today we are going to talk about the connection between complaints, CAPAs, and MDRs. They are all in...
8 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

8 Tips to Comply With FDA 21 CFR Part 11

  When it comes to compliance among medical device companies, there is a lot of misleading informati...
When Design Inputs Go Wrong + Design Your Label Like You Design Your Device - Featured Image

When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

Today’s guest is Mike Drues, the president of Vascular Sciences and a world-renowned expert on all t...
EU-MDR and EU-IVDR Are Live – Here Are Some Important Items You Should Know! - Featured Image

EU-MDR and EU-IVDR Are Live – Here Are Some Important Items You Should Know!

After almost 10 years of careful deliberations, the new EU regulations on medical devices finally ha...
A Revised Guideline for Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4 - Featured Image

A Revised Guideline for Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4

Editor's Note: This article was originally published by  Florian Tolkmitt on Medium and is being rep...
Better Root Cause Analysis for Safer, More Effective Medical Devices - Featured Image

Better Root Cause Analysis for Safer, More Effective Medical Devices

Have you really figured out the root cause of any issues found in your medical device company?
The Intersection of Medical Device Usability and Risk Management - Featured Image

The Intersection of Medical Device Usability and Risk Management

Today we’re going to be talking to our good friend Mike Drues from Vascular Sciences about the inter...
CAPA: When to Take Corrective Action or Preventive Action? - Featured Image

CAPA: When to Take Corrective Action or Preventive Action?

How many of you can confidently initiate a CAPA and know exactly how and what to do and the process ...
What is a “Quality Data Source” for your CAPA Process? - Featured Image

What is a “Quality Data Source” for your CAPA Process?

There’s a phrase that the FDA states in their policies around CAPA, which elicits a few questions. T...
Tips for Conducting Better Root Cause Analysis for Medical Device Companies - Featured Image

Tips for Conducting Better Root Cause Analysis for Medical Device Companies

At some point, every medical device development company will encounter an issue that requires an inv...
This is a What … Unforeseen Pitfalls when Classifying a Medical Device - Featured Image

This is a What … Unforeseen Pitfalls when Classifying a Medical Device

“This is a what” is not only a torturous summer-camp game, but an essential question when working to...
How FDA Interacts with Medical Devices When They Are Imported Into the US - Featured Image

How FDA Interacts with Medical Devices When They Are Imported Into the US

Does your medical device company import components, parts, or materials used in the development or m...
What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

Over years of working with medical device companies, we’ve found that there is a particular area tha...
How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster - Featured Image

How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster

In today’s episode we continue our series on new breed medical device company stories. We talk with ...
EN ISO 14971:2012 Risk Assessment Explained in 5 Minutes… Using the Grossest Example Ever? - Featured Image

EN ISO 14971:2012 Risk Assessment Explained in 5 Minutes… Using the Grossest Example Ever?

  This post was originally published by David Amor on LinkedIn and reposted here with the author's p...
Fundamentals of Supplier Management for Medical Device Companies - Featured Image

Fundamentals of Supplier Management for Medical Device Companies

As a manufacturer of medical devices, it is your responsibility to be on top of the entire system th...
An Overview of What Device Makers Need to Know About CAPA - Featured Image

An Overview of What Device Makers Need to Know About CAPA

Today we will be talking about a topic that seems to be an area of continual concern and, in some ca...
Key Actions for Effective Customer Complaint Handling - Featured Image

Key Actions for Effective Customer Complaint Handling

  Let's say, your medical device business has received a complaint from a customer. It happens to al...
5 Tips for Medical Device Engineers on FDA Design Controls - Featured Image

5 Tips for Medical Device Engineers on FDA Design Controls

If you’re in the medical device industry, you may think that design controls are a confusing imposit...
How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance - Featured Image

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

At greenlight.guru, we would like to continue our series on the new breed of medical device companie...
9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit - Featured Image

9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit

Most of us really don’t get excited by the prospect of any kind of audit. The procedures, the paperw...
Best Practices for Expediting Your Medical Device Product Development - Featured Image

Best Practices for Expediting Your Medical Device Product Development

Speed to market is one of the major challenges for medical device companies; how can you expedite th...
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? - Featured Image

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

Do you understand the difference between significant risk and nonsignificant risk when it comes to t...
4 Key Compliance Issues for Medical Device Companies - Featured Image

4 Key Compliance Issues for Medical Device Companies

The goal for most creators of new medical devices is to be able to get them to market as quickly as ...
What is CAPA in the Medical Device Industry? - Featured Image

What is CAPA in the Medical Device Industry?

If you’re relatively new to the medical device development industry, you will have worked out fairly...
Key Challenges for Risk Management in Medical Device Development - Featured Image

Key Challenges for Risk Management in Medical Device Development

If you’re in the business of developing medical devices, then risk and risk management become terms ...
What Devicemakers Need to Know About Medical Device Reporting (MDR) - Featured Image

What Devicemakers Need to Know About Medical Device Reporting (MDR)

Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?
How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan - Featured Image

How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan

What if regulatory affairs were not only viewed as a necessary burden, but actually help a medical d...
5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare) - Featured Image

5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)

What should the medical device industry expect in 2017? Great question. I’d like to share some of my...
A Review of the Most Important Medical Device Industry Topics in 2016 - Featured Image

A Review of the Most Important Medical Device Industry Topics in 2016

2016 was a very active and monumental year for the medical device industry. There were several impor...
2016 Medical Device Regulatory Trends Year in Review - Featured Image

2016 Medical Device Regulatory Trends Year in Review

We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On toda...
Top 10 Most Popular Medical Device Articles of 2016 from greenlight guru (Plus Top 5 Free Webinars and Podcasts) - Featured Image

Top 10 Most Popular Medical Device Articles of 2016 from greenlight guru (Plus Top 5 Free Webinars and Podcasts)

Thanks for helping make 2016 another big and exciting year for Greenlight Guru filled with growth! W...
Using the Bucket Method for Medical Device Risk Management - Featured Image

Using the Bucket Method for Medical Device Risk Management

Risk management: It’s a topic that needs to be navigated carefully by medical device companies. It’s...
Tips for Success When It Comes to IEC 60601 with Leo Eisner - Featured Image

Tips for Success When It Comes to IEC 60601 with Leo Eisner

  IEC 60601 is a challenge for companies that are developing electronic medical devices. It’s wise t...
The Business Case for Integrated Design Controls - Featured Image

The Business Case for Integrated Design Controls

What role do you believe design controls play in the growth and stability of your company? I suspect...
How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources - Featured Image

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

Zebra Medical Technologies is part of a new breed of medical device companies. They understand the r...
Medical Device Risk – ISO 14971 Gets It Right - Featured Image

Medical Device Risk – ISO 14971 Gets It Right

Editor's note: This is a guest post authored by William Storage, VP LiveSky Inc., Visiting Scholar, ...
Understanding the New FDA Guidance on Changes to a 510(k) - Featured Image

Understanding the New FDA Guidance on Changes to a 510(k)

What happens you need to make a change to a device that’s been cleared via 510(k)?
An Introduction to FDA 21 CFR Part 11 - Featured Image

An Introduction to FDA 21 CFR Part 11

Every week that goes by, I talk to several medical device companies all over the world who have esta...
What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two) - Featured Image

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

FDA Pre-submissions: They're a hot, timely topic.
Preparing for the Changes to the EU Medical Device and In-ViTRo Diagnostics Regulations - Featured Image

Preparing for the Changes to the EU Medical Device and In-ViTRo Diagnostics Regulations

Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Di...
ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820 - Featured Image

ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820

The publication and release of ISO 13485:2016 earlier this year is a significant movement for the me...
Tips for Avoiding Problems with the First-In-Human Study Process - Featured Image

Tips for Avoiding Problems with the First-In-Human Study Process

When it comes to moving from the conceptual phase of developing a medical device and actually doing ...
What's with the Rush to First-In-Human Studies? - Featured Image

What's with the Rush to First-In-Human Studies?

Any medical device initially starts with an idea — a problem to solve, with the hope of positively i...
Tips & Pointers for Effective Internal Quality Audits with Kyle Rose - Featured Image

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Internal audits might be inconvenient and a bit nerve-wracking, but they’re also educational.
How to Properly Use the FDA Pre-Submission Process and Why It's So Important - Featured Image

How to Properly Use the FDA Pre-Submission Process and Why It's So Important

In order to get your medical device to market, you will need to know about pre-submissions and the p...
Why Poor Design Controls Mean More Medical Device Complaints - Featured Image

Why Poor Design Controls Mean More Medical Device Complaints

I’ll venture a guess that you want to get your medical device to market ASAP!
Greenlight Guru Invited to Host Two Workshop Sessions at RAPS Convergence San Jose 2016 - Featured Image

Greenlight Guru Invited to Host Two Workshop Sessions at RAPS Convergence San Jose 2016

Be sure to come out and meet some of the Greenlight Guru team at the RAPS Convergence in San Jose Se...
How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time - Featured Image

How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time

Did you know that 69% of 510(k) submissions were rejected the first time between January and June of...
Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer - Featured Image

Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer

One important piece of documentation that medical device companies rely on to get them through the r...
Why Use ISO 14971 vs. FMEA (Template Included) - Featured Image

Why Use ISO 14971 vs. FMEA (Template Included)

This may be stating the obvious, but engineers are generally very analytical. One of the areas where...
Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development - Featured Image

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

3D printing can impact new product development and manufacturing. It’s a technology that is hot in m...
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): Understanding the Differences and What Documents to Include - Featured Image

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): Understanding the Differences and What Documents to Include

DHF. DMR. DHR. It’s bad enough that medical device product development has a whole slew of new terms...
3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
5 Places Paper Might Be Hiding in Your Medical Device Company - Featured Image

5 Places Paper Might Be Hiding in Your Medical Device Company

A few weeks ago you left a big pile of paperwork (also known as your Document Change Order (DCO/ECO)...
3 Common Misconceptions About Medical Device Labeling - Featured Image

3 Common Misconceptions About Medical Device Labeling

When you first start designing and developing a new medical device, you spend a bunch of time learni...
What It Means to Join the Greenlight Guru Family - Featured Image

What It Means to Join the Greenlight Guru Family

When your medical device company makes the decision to go with Greenlight Guru, you might think that...
Recovery Force Accelerates Their Product Development Efforts Using greenlight guru [Case Study] - Featured Image

Recovery Force Accelerates Their Product Development Efforts Using greenlight guru [Case Study]

With its innovative technology in the highly competitive and expanding compression therapy market, i...
8 Reasons Why Your Design Controls And Risk Management Processes Fail - Featured Image

8 Reasons Why Your Design Controls And Risk Management Processes Fail

Design controls and risk management processes should be tools for medtech professionals to ensure th...
What Medtech Startups Should Know About Quality Systems To Not Go Overboard - Featured Image

What Medtech Startups Should Know About Quality Systems To Not Go Overboard

Medtech startups thrive on lean-ness. Part of lean-ness is knowing how and when to scale regulatory ...
Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner - Featured Image

Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner

If you are part of an organization developing or producing Class II medical devices, you should know...
5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time - Featured Image

5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time

If you’re an engineer at a small medical device company, chances are, at some point, you’re going to...
7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included) - Featured Image

7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included)

Attention: If you are a medical device company and you have class II or class III products registere...
Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon? - Featured Image

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

As medical device developers, it is our responsibilities to make sure that our products are safe and...
4 Medical Device Quality System Musts for Startups - Featured Image

4 Medical Device Quality System Musts for Startups

Medical device startups have a pile of things to address yet often don’t have the pile of money to t...
4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer - Featured Image

4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer

As an engineer, there’s not a lot that makes me nervous.   Going through an FDA / ISO audit?   That ...
Tips to Help You Prepare for an FDA Inspection - Featured Image

Tips to Help You Prepare for an FDA Inspection

On today’s episode, we’re introducing the newest addition to the Greenlight Guru team, Jesseca Lyons...
Best Practices for an Effective Medical Device Design Transfer Process - Featured Image

Best Practices for an Effective Medical Device Design Transfer Process

With everything there is out there on the subject of Design Controls, you’d expect to find more on t...
Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015 - Featured Image

Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015

When was your last FDA inspection? You may believe that the likelihood of an FDA inspection happenin...
What Device Makers Need to Know About Design Verification and Validation with Mike Drues - Featured Image

What Device Makers Need to Know About Design Verification and Validation with Mike Drues

Here’s a question for our listeners: When it comes to making sure your medical devices are safe and ...
Understanding Risk in Medical Device New Product Development (NPD) - Featured Image

Understanding Risk in Medical Device New Product Development (NPD)

Editor's Note: This is a guest post by Jeff Groh, President at New Product Visions and was originall...
Why Integrating Business Elements into Your Medtech Development Process Is So Important with Therese Graff - Featured Image

Why Integrating Business Elements into Your Medtech Development Process Is So Important with Therese Graff

On today’s episode of the Global Medical Device podcast, we’re talking about the importance of incor...
How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso - Featured Image

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Getting started in the medical product development process can be a huge undertaking. You might have...
Debunking 4 Commonly Held Design Control Myths - Featured Image

Debunking 4 Commonly Held Design Control Myths

The design control struggle is real. What is the struggle, you ask? Design controls are not being us...
3 Tips for Managing Your Medical Device Design History File - Featured Image

3 Tips for Managing Your Medical Device Design History File

Developing a cutting edge medical device can be really fun and exciting. There’s always something to...
The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important) - Featured Image

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

It’s time to break down the how and why of intended use and indications of use statements for your n...
Is Your Company Disconnected from the Medical Device Regulations It Must Abide By? - Featured Image

Is Your Company Disconnected from the Medical Device Regulations It Must Abide By?

As I type this post, I must admit that I’m a little perplexed. It seems medical device company after...
8 Questions That Define Your Medical Device User Needs - Featured Image

8 Questions That Define Your Medical Device User Needs

When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a l...
Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong with David Amor - Featured Image

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong with David Amor

Today on the Global Medical Device Podcast we have a very interesting and highly debated topic for y...
Acronyms You Need To Know When Evaluating Medical Device Software Solutions - Featured Image

Acronyms You Need To Know When Evaluating Medical Device Software Solutions

Ah, yes! You aspire to run your device company in a paperless environment. Allowing you to capture a...
6 Medical Device Product Development Steps To Fast-Track Your Path To Market - Featured Image

6 Medical Device Product Development Steps To Fast-Track Your Path To Market

This article originally appeared as a guest expert post on Med Device Online. Congratulations! You h...
Why Medical Device Startups Need to Master Juggling and Balancing With Focus - Featured Image

Why Medical Device Startups Need to Master Juggling and Balancing With Focus

Medical device startups are faced with numerous challenges and obstacles to get their products to ma...
How Design Controls Apply to a 510(k) - Featured Image

How Design Controls Apply to a 510(k)

If you are developing a medical device for the U.S. market, you first need to determine how your dev...
Why FMEA is Not ISO 14971 Risk Management - Featured Image

Why FMEA is Not ISO 14971 Risk Management

If you are still using FMEA as your methodology to capture medical device risk management activities...
Top 3 Document Management Tips for Medical Device Companies - Featured Image

Top 3 Document Management Tips for Medical Device Companies

This co-authored article originally appeared as a guest post on Quality Digest. In the medical devic...
Medical Device Product Development Project Management Best Practices with Peter Sebelius - Featured Image

Medical Device Product Development Project Management Best Practices with Peter Sebelius

Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the fo...
How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls - Featured Image

How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls

Click here to enlarge image. The story I’m about to tell you is about Eddy Engineer and his trials a...
4 Reasons Why Your Risk Management Approach is Wrong - Featured Image

4 Reasons Why Your Risk Management Approach is Wrong

This article originally appeared as a guest post on MedTech Intelligence. A few months ago, I predic...
Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner - Featured Image

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

Standards are absolutely critical when you are developing a medical device. You need to understand w...
Best Document Management Practices for Medical Device Startups: Don’t Cheap Out - Featured Image

Best Document Management Practices for Medical Device Startups: Don’t Cheap Out

This guest post by Alex Morris, Founder of Frontline Health Consulting, originally appeared on his p...
The Risk Management + Design Controls Connection: What Device Makers Need to Know - Featured Image

The Risk Management + Design Controls Connection: What Device Makers Need to Know

This eBook was originally published as a guest expert three, part, series on Med Device Online. You ...
An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson, a Member of the Standard's Working Group - Featured Image

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson, a Member of the Standard's Working Group

Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later thi...
The Definitive Guide to Responding to FDA 483 Observations and Warning Letters - Featured Image

The Definitive Guide to Responding to FDA 483 Observations and Warning Letters

Should you ever have an FDA inspection, you’re going to want to know what to do after. And if you’re...
ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements - Featured Image

ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements

Medical device companies, listen up. There is zero excuse for not complying with medical device qual...
The Greenlight Guru Advantage - More Than QMS Software [Customer Video Testimonial] - Featured Image

The Greenlight Guru Advantage - More Than QMS Software [Customer Video Testimonial]

What do you know about Greenlight Guru? Your first thought may be that Greenlight Guru is a software...
Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities - Featured Image

Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities

This article was originally published on Med Device Online as part of my guest expert series. You ca...
Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor - Featured Image

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

If you are in the business of medical devices, then you must eat, breathe, and live quality manageme...
20 Most Popular Medical Device Posts of 2015 from greenlight guru - Featured Image

20 Most Popular Medical Device Posts of 2015 from greenlight guru

2015 was a huge year for Greenlight Guru! A lot happened. From publically launching our product in F...
Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey - Featured Image

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

In episode #10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt...
Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It) - Featured Image

Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)

Getting FDA 510(k) market clearance is a significant, meaningful milestone and achievement for any m...
LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development - Featured Image

LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development

  "Medical device companies must document Design Controls, yet most struggle with this. Greenlight G...
Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru - Featured Image

Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru

“The proof is in the pudding. We passed our California audit with flying colors. She was in and out ...
5 Reasons Why You Need To Implement a QMS or Bust - Featured Image

5 Reasons Why You Need To Implement a QMS or Bust

Look, I get it. Worrying about implementing a quality management system isn't on your list of the to...
How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans - Featured Image

How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

In episode #9 of the Global Medical Device Podcast we’re joined by Mike Cremeans. Mike is the Vice P...
How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues - Featured Image

How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues

In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascu...
15 Items Medical Device Startups Need to Address - Featured Image

15 Items Medical Device Startups Need to Address

As a medical device startup, there are many things you are juggling and balancing all day, every day...
Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson - Featured Image

Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

We’re discussing how startup entrepreneurs like you can remove the common regulatory obstacles your ...
Paper Systems Are the Riskiest Way to Manage Medical Device Projects - Featured Image

Paper Systems Are the Riskiest Way to Manage Medical Device Projects

Did you know that over 50% of medical device companies still use manual, paper-based approaches for ...
greenlight guru Wins 2015 Indiana Innovation Award - Featured Image

greenlight guru Wins 2015 Indiana Innovation Award

   
Medical Device Classification - How Your Medical Device Will Be Classified - Featured Image

Medical Device Classification - How Your Medical Device Will Be Classified

What I am about to share with you is a guide to medical device regulatory classification. In this gu...
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong - Featured Image

The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong

Editor's Note: This article was orginal published on Med Device Online. Risk assessment and risk man...
How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken - Featured Image

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

What are the most common mistakes a startup medical device company usually make? Hear Ronny Bracken ...
Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Companies - Featured Image

Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Companies

In today’s episode of the Global Medical Device Podcast Jon Speer welcomes Sara Naab to the show.
How To Prepare for an FDA Inspection (Plus 5 Tips) - Featured Image

How To Prepare for an FDA Inspection (Plus 5 Tips)

Over the past several years, FDA has been more aggressive and active in performing medical device co...
Does Your Medical Device Startup Suffer from CEO Disconnect Syndrome? - Featured Image

Does Your Medical Device Startup Suffer from CEO Disconnect Syndrome?

I’d like to take a few minutes to share with you a story. One where a CEO of a medical device startu...
Risk Management from a Regulatory & Product Development Perspective [Podcast] - Featured Image

Risk Management from a Regulatory & Product Development Perspective [Podcast]

  Risk management for medical devices from a regulatory and product development perspective is the t...
How To Flush $400,000 Down the Drain Fighting the FDA - Featured Image

How To Flush $400,000 Down the Drain Fighting the FDA

How much does it cost to address FDA 483 observation and warning letter issues? Unless you have been...
How To Improve Your Design Reviews (Bonus Episode) - Featured Image

How To Improve Your Design Reviews (Bonus Episode)

Medical device design reviews - are more or less better? What about independent reviews? Are they ne...
3 Tips for Incorporating Risk Management Throughout Medical Device Product Development - Featured Image

3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

Medical device product development and risk management are often treated as entirely separate proces...
Understanding ISO 14971 Medical Device Risk Management - Featured Image

Understanding ISO 14971 Medical Device Risk Management

Medical device companies MUST have established risk management processes that comply with ISO 14971....
Design Reviews – Are More or Less Better? - Featured Image

Design Reviews – Are More or Less Better?

Design Reviews are critical to the success of medical device product development.  So much so that t...
A Brief Introduction to Medical Device Risk Management (Plus 5 Tips) - Featured Image

A Brief Introduction to Medical Device Risk Management (Plus 5 Tips)

Risk management will have the most significant impact on the medical device industry within the next...
How To Improve Your Medical Device Design Reviews - Featured Image

How To Improve Your Medical Device Design Reviews

Medical device Design Reviews are critical steps within your design and development process. They pr...
How To Avoid a Medtech Documents & Records Scavenger Hunt - Featured Image

How To Avoid a Medtech Documents & Records Scavenger Hunt

I love a scavenger hunt as much as the next person. However, when it comes to medical device documen...
Join Us in Memphis for #ZeroToGreenlight - Why Worrying About FDA Regulations Matters - Featured Image

Join Us in Memphis for #ZeroToGreenlight - Why Worrying About FDA Regulations Matters

Clear your calendar - It's going down! As part of the ZeroTo510 Thought Leaders Series, Zero To Gree...
Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation? - Featured Image

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

Superbugs.  Reprocessing. The White House. And Design Controls. Probably not a combo of topics you s...
5 Tips to Help Your FDA 510(k) Submission (checklist included) - Featured Image

5 Tips to Help Your FDA 510(k) Submission (checklist included)

If you are developing a medical device in the United States, there is a good chance your path to mar...
The Beginner's Guide to Design Verification and Design Validation for Medical Devices - Featured Image

The Beginner's Guide to Design Verification and Design Validation for Medical Devices

When your medical device product development project gets to Design Verification and Design Validati...
Best Practices for Implementing Design Controls for the Medical Device Industry - Featured Image

Best Practices for Implementing Design Controls for the Medical Device Industry

If you're like many in the medical device industry, you've probably had some questions at one time o...
The Art of Defining Design Inputs And Design Outputs - Featured Image

The Art of Defining Design Inputs And Design Outputs

Design Inputs are the king of medical device product development. If a product that is in the market...
Best Practices for Effective Medical Device Design Reviews - Featured Image

Best Practices for Effective Medical Device Design Reviews

Design Reviews are intended to be checkpoints during medical device product development to ensure th...
2 Things You Need To Do ASAP When Starting A Medical Device Project - Featured Image

2 Things You Need To Do ASAP When Starting A Medical Device Project

It's hard to believe I've been in the medical device industry since 1998. I have learned so much and...
How To Reduce & Prevent Medical Device Complaints - Featured Image

How To Reduce & Prevent Medical Device Complaints

Congratulations! You have successfully launched a new medical device after months and months of prod...
Medical Device Product Development Case Study - Featured Image

Medical Device Product Development Case Study

Medical Device product development is a very challenging endeavor. Even the simplest product develop...
Changing Medical Device Design Control - Featured Image

Changing Medical Device Design Control

This post about Design Control comes from Greenlight Guru early adopter, Leland Stock. Find out more...
You do know Design Controls are required for medical devices, right? - Featured Image

You do know Design Controls are required for medical devices, right?

So you're developing a medical device? Congratulations! Medical device product development can be qu...
An FDA Inspection Will Happen - Featured Image

An FDA Inspection Will Happen

If you are a medical device company in the U.S., did you know FDA is required to inspect all class I...
Design Controls Need to Start With User Needs - Featured Image

Design Controls Need to Start With User Needs

If you are engaged in medical device product development, then you likely know about the importance ...
Design Controls are the #1 Most Cited Issue with FDA - Featured Image

Design Controls are the #1 Most Cited Issue with FDA

Did you know that Design Controls were the #1 issue cited by FDA during 2013? Of the 4000+ 483 inves...

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