Medical Device Quality, Regulatory and Product Development Blog

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

By Mary Beth Privitera, PhD, FIDSA on June 18, 2018

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

By Jon Speer on June 11, 2018

Human factors can be a topic rife with confusion for medical device developers. What do they mean?...

Tips for Running Effective Internal Quality Audits

By Jon Speer on June 4, 2018

How did your last internal quality audit go?

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

By Nick Tippmann on May 25, 2018

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

By Nick Tippmann on May 25, 2018

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

By Nick Tippmann on May 25, 2018

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

By Nick Tippmann on May 20, 2018

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)

By Nick Tippmann on May 15, 2018

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)

By Edwin Bills, ASQ Fellow, RAC on May 14, 2018

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

By Nick Tippmann on May 8, 2018

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

By Nick Tippmann on May 7, 2018

Functionality enables visibility into multiple workspaces, holistic view of design components and a ...

The Ultimate Guide To Design Controls For Medical Device Companies

By Jon Speer on May 7, 2018

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

By Jon Speer on April 30, 2018

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

By Nick Tippmann on April 24, 2018

Students offer hope for our future. They will be developing products that can save our lives, or at ...

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

By Nick Tippmann on April 23, 2018

Are you a smart, talented and ambitious individual looking to be surrounded by other elite performer...

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

By Jon Speer on April 23, 2018

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

By Nick Tippmann on April 19, 2018

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)

By Jon Speer on April 15, 2018

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)

By Jon Speer on April 9, 2018

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

By Jon Speer on March 26, 2018

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

By Nick Tippmann on March 21, 2018

What are the most common problems with the CAPA process?

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

By Kyle Rose on March 19, 2018

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

By Nick Tippmann on March 14, 2018

Are you ready for audits? ISO? FDA? Is your quality management system working the way you want it to...

Quality Management Audit or Assessment?

By Larry Mager on March 12, 2018

What's the difference? Plenty! A typical audit only provides a sample understanding of the complianc...

Understanding the 5 Phases of Medical Device Development

By Adnan Ashfaq on March 5, 2018

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

By Nick Tippmann on February 21, 2018

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]

By Jon Speer on February 20, 2018

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

By Jon Speer on February 12, 2018

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

By Rod Beuzeval on January 30, 2018

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)

By Jon Speer on January 21, 2018

As your company heads back from holiday breaks, what’s happening into the New Year?

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

By Nick Tippmann on January 12, 2018

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

By Nick Tippmann on January 10, 2018

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)

By Jon Speer on January 8, 2018

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

By Nick Tippmann on December 25, 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

By Nick Tippmann on December 20, 2017

The topic of human factors can be confusing: How does it relate to design factors and risk? Why is i...

15 Steps to Getting Approval for IEC 60601-1

By Jon Speer on December 18, 2017

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

By Nick Tippmann on December 11, 2017

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

By Jon Speer on December 5, 2017

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

By Nick Tippmann on November 29, 2017

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

By Jon Speer on November 27, 2017

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

By Nick Tippmann on November 20, 2017

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

By Nick Tippmann on November 16, 2017

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)?

By Jon Speer on November 13, 2017

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

By Nick Tippmann on November 8, 2017

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

By Jon Speer on November 6, 2017

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

By Nick Tippmann on October 30, 2017

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

By Jon Speer on October 27, 2017

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

By Jon Speer on October 23, 2017

How is your understanding of the Medical Device Single Audit Program (MDSAP)?

Lessons to Be Learned from Recent FDA Inspections

By Nick Tippmann on October 18, 2017

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

By Jon Speer on October 16, 2017

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

By Jon Speer on October 11, 2017

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

By Jon Speer on October 9, 2017

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?

By Jon Speer on October 1, 2017

What exactly is a risk-based QMS? This is a timely topic to get into. In 2016, ISO 13485 was updated...

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

By Jon Speer on September 24, 2017

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?

By Jon Speer on September 18, 2017

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

By Jon Speer on September 11, 2017

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)

By Nick Tippmann on August 30, 2017

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

By Jon Speer on August 28, 2017

The FDA has arrived at your premises…

How to Translate Voice of Customer into User Needs

By Nichole Leahy-Glass on August 21, 2017

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

By Nick Tippmann on August 18, 2017

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)

By Jon Speer on August 13, 2017

So, you haven’t completed your design controls or design history file (DHF)...

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

By Jon Speer on August 8, 2017

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

By Nick Tippmann on August 2, 2017

Today, we are talking to Mike Fisher, who is the director of product development at the Global Cente...

Debunking 8 Commonly Held CAPA Myths

By Jon Speer on July 30, 2017

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

By Jon Speer on July 23, 2017

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

By Nick Tippmann on July 21, 2017

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

By Jon Speer on July 9, 2017

Are you falling into some of the common traps that surround medical device product development?

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

By Jon Speer on June 30, 2017

How confident are you when it comes to design validation? Does this always involve clinical evaluati...

5 Tips for Conducting Medical Device Management Reviews

By Jon Speer on June 23, 2017

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

By Jon Speer on June 18, 2017

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

By Jon Speer on June 9, 2017

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

By Nick Tippmann on May 31, 2017

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

By Nick Tippmann on May 24, 2017

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

By Jon Speer on May 22, 2017

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

By Nick Tippmann on May 17, 2017

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!

By Dr. Gert W. Bos on May 16, 2017

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

By Florian Tolkmitt on May 11, 2017

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

By Jon Speer on May 8, 2017

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

By Nick Tippmann on April 27, 2017

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?

By Jon Speer on April 25, 2017

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?

By Jon Speer on April 17, 2017

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

By Jon Speer on April 10, 2017

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

By John F. Johnson III on April 7, 2017

“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

By Nick Tippmann on April 5, 2017

Does your medical device company import components, parts, or materials used in the development or m...

What Should Really Trigger a CAPA?

By Jon Speer on April 4, 2017

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

By Nick Tippmann on March 29, 2017

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?

By David Amor on March 27, 2017

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

By Jesseca Lyons on March 19, 2017

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

By Nick Tippmann on March 15, 2017

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

By Jon Speer on March 14, 2017

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

By Jon Speer on March 6, 2017

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

By Nick Tippmann on March 2, 2017

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

By Jon Speer on February 28, 2017

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

By Jon Speer on February 20, 2017

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?

By Nick Tippmann on February 14, 2017

Do you understand the difference between significant risk and nonsignificant risk when it comes to t...

4 Key Compliance Issues for Medical Device Companies

By Jon Speer on February 11, 2017

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?

By Jon Speer on February 6, 2017

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

By Jon Speer on January 29, 2017

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)

By Nick Tippmann on January 25, 2017

Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?

The Ultimate Guide to Preparing Your FDA 510(k) Submission

By Jesseca Lyons on January 17, 2017

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...

How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan

By Nick Tippmann on January 12, 2017

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)

By Jon Speer on January 9, 2017

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

By Jon Speer on January 3, 2017

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

By Nick Tippmann on December 29, 2016

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

Using the Bucket Method for Medical Device Risk Management

By Nick Tippmann on December 6, 2016

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

By Nick Tippmann on November 22, 2016

IEC 60601 is a challenge for companies that are developing electronic medical devices. It’s wise t...

The Business Case for Integrated Design Controls

By Jon Speer on November 20, 2016

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

By Nick Tippmann on November 8, 2016

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

By William Storage on November 7, 2016

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)

By Nick Tippmann on October 26, 2016

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

By Jon Speer on October 25, 2016

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)

By Nick Tippmann on October 19, 2016

FDA Pre-submissions: They're a hot, timely topic.

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

By Nick Tippmann on October 12, 2016

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: Comparing the Differences and Changes

By Jon Speer on October 10, 2016

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

By Nick Tippmann on October 4, 2016

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?

By Jon Speer on September 26, 2016

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

By Nick Tippmann on September 12, 2016

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

By Nick Tippmann on August 31, 2016

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

By Jon Speer on August 29, 2016

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

By Nick Tippmann on August 17, 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

By Jon Speer on August 15, 2016

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

By Nick Tippmann on August 11, 2016

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)

By Jesseca Lyons on August 1, 2016

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

By Nick Tippmann on July 28, 2016

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

By Jesseca Lyons on July 25, 2016

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

By Jesseca Lyons on July 18, 2016

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

By Jesseca Lyons on July 11, 2016

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

By Jesseca Lyons on June 29, 2016

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

By Jesseca Lyons on June 27, 2016

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]

By Nick Tippmann on June 22, 2016

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

By Jon Speer on June 20, 2016

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

By David Amor on June 16, 2016

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

By Nick Tippmann on June 14, 2016

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

By Jesseca Lyons on June 13, 2016

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)

By Jon Speer on June 8, 2016

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?

By Nick Tippmann on June 1, 2016

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

By Jon Speer on May 31, 2016

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

By Jesseca Lyons on May 24, 2016

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

By Nick Tippmann on May 23, 2016

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

By Jesseca Lyons on May 23, 2016

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

By Jon Speer on May 16, 2016

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

By Nick Tippmann on May 10, 2016

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)

By Jeff Groh on May 9, 2016

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

By Nick Tippmann on May 4, 2016

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

By Nick Tippmann on April 27, 2016

Getting started in the medical product development process can be a huge undertaking. You might have...

Debunking 4 Commonly Held Design Control Myths

By Jon Speer on April 25, 2016

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

By Jon Speer on April 21, 2016

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)

By Nick Tippmann on April 19, 2016

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?

By Jon Speer on April 14, 2016

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

By Jon Speer on April 7, 2016

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

By Nick Tippmann on March 30, 2016

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

By Jon Speer on March 29, 2016

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

By Jon Speer on March 28, 2016

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

By Jon Speer on March 17, 2016

Medical device startups are faced with numerous challenges and obstacles to get their products to ma...

How Design Controls Apply to a 510(k)

By Jon Speer on March 14, 2016

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

By Jon Speer on March 10, 2016

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

Medical Device Product Development Project Management Best Practices with Peter Sebelius

By Nick Tippmann on February 23, 2016

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

By Jon Speer on February 22, 2016

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

By Jon Speer on February 16, 2016

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

By Nick Tippmann on February 10, 2016

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

By Alex Morris on February 4, 2016

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

By Jon Speer on February 1, 2016

This eBook was originally published as a guest expert three, part, series on Med Device Online. Yo...

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

By Jon Speer on January 18, 2016

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

By Jon Speer on January 13, 2016

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

By Jon Speer on January 4, 2016

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]

By Jon Speer on December 28, 2015

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

By Jon Speer on December 22, 2015

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

By Nick Tippmann on December 15, 2015

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

By Nick Tippmann on December 14, 2015

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

By Nick Tippmann on December 9, 2015

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)

By Jon Speer on December 9, 2015

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

By Jon Speer on December 3, 2015

"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

By Jon Speer on December 2, 2015

“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

By Jon Speer on December 1, 2015

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

By Nick Tippmann on November 25, 2015

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

By Nick Tippmann on November 20, 2015

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

By Jon Speer on November 16, 2015

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

By Nick Tippmann on November 4, 2015

On today's episode of the Global Medical Device Podcast, we’re discussing how startup entrepreneurs ...

Paper Systems Are the Riskiest Way to Manage Medical Device Projects

By Jon Speer on October 28, 2015

Did you know that over 50% of medical device companies still use manual, paper-based approaches for ...

greenlight.guru Wins 2015 Indiana Innovation Award

By Nick Tippmann on October 23, 2015

A Step-by-Step Guide to Determine How Your Medical Device Will Be Classified

By Jon Speer on October 20, 2015

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

By Jon Speer on October 5, 2015

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

By Michael Drues, Ph.D. on September 28, 2015

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

By Nick Tippmann on September 22, 2015

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

By Nick Tippmann on September 17, 2015

In today’s episode of the Global Medical Device Podcast Jon Speer welcomes Sara Naab to the show. Sa...

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

By Jon Speer on September 14, 2015

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?

By Jon Speer on September 10, 2015

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]

By Nick Tippmann on September 2, 2015

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

By Jon Speer on August 31, 2015

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)

By Nick Tippmann on August 14, 2015

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

By Jon Speer on August 10, 2015

Medical device product development and risk management are often treated as entirely separate proces...

Understanding ISO 14971 Medical Device Risk Management

By Jon Speer on August 6, 2015

Medical device companies MUST have established risk management processes that comply with ISO 14971....

Design Reviews – Are More or Less Better?

By Jon Speer on August 3, 2015

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)

By Jon Speer on July 15, 2015

Risk management will have the most significant impact on the medical device industry within the next...

How To Improve Your Medical Device Design Reviews

By Nick Tippmann on July 7, 2015

"Medical device Design Reviews are critical steps within your design and development process. They ...

How Smart Medical Device Startups Avoid FDA Disasters [Panel Recap]

By Nick Tippmann on June 26, 2015

[&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;a href="//storify.com/green...

How To Avoid a Medtech Documents & Records Scavenger Hunt

By Jon Speer on June 19, 2015

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

By Nick Tippmann on June 18, 2015

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?

By Nick Tippmann on June 12, 2015

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)

By Jon Speer on May 21, 2015

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

By Jon Speer on May 6, 2015

When your medical device product development project gets to Design Verification and Design Validati...

[Podcast] Best Practices for Implementing Design Controls for the Medical Device Industry

By Nick Tippmann on April 16, 2015

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

By Jon Speer on March 3, 2015

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

By Jon Speer on February 24, 2015

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

By Jon Speer on February 17, 2015

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

By Jon Speer on November 13, 2014

Congratulations! You have successfully launched a new medical device after months and months of prod...

Medical Device Product Development Case Study

By Jon Speer on October 3, 2014

Medical Device product development is a very challenging endeavor. Even the simplest product develop...

Changing Medical Device Design Control

By Jon Speer on September 18, 2014

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?

By Jon Speer on September 9, 2014

So you're developing a medical device? Congratulations! Medical device product development can be qu...

An FDA Inspection Will Happen

By Jon Speer on August 30, 2014

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

By Jon Speer on August 21, 2014

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

By Jon Speer on August 9, 2014

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

Greenlight Guru Medical Device Blog

Get the latest updates from our blog: