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7 Project Management Tips - Featured Image

7 Project Management Tips

When I began my medical device career, I started as a product development engineer. Part of the role...
Project Management for Product Development of Medical Devices - Featured Image

Project Management for Product Development of Medical Devices

How should you approach project management for medical device product development ? Stop managing yo...
What’s the Difference Between Clinical Evaluation and Clinical Investigation? - Featured Image

What’s the Difference Between Clinical Evaluation and Clinical Investigation?

Within the myriad of regulations and standards governing medical devices, there are a number of simi...
IEC 62366 Explained: What You Need To Know About Usability Engineering - Featured Image

IEC 62366 Explained: What You Need To Know About Usability Engineering

Usability engineering (UE)—or human factors engineering (HFE), as it’s also known—is focused on desi...
Medical Device 3D Printing: Should You Make the Move? - Featured Image

Medical Device 3D Printing: Should You Make the Move?

The medical device industry has grown immensely over the past several decades. But with new technolo...
Clinical Testing for Medical Devices: What US Manufacturers Need to Know - Featured Image

Clinical Testing for Medical Devices: What US Manufacturers Need to Know

Clinical testing of medical devices is a critically important step in ensuring the safety and effica...
Assessing the Global Regulatory Landscape - Featured Image

Assessing the Global Regulatory Landscape

With medical device regulations tightening around the world, especially in Europe, it's important to...
Ultimate Guide to QA & RA in Medical Device 3D Printing - Featured Image

Ultimate Guide to QA & RA in Medical Device 3D Printing

This document aims to guide users in the medical device industry through every stage of the product ...
Choosing an EU Authorised Representative (EC REP) for Medical Device Regulatory Issues - Featured Image

Choosing an EU Authorised Representative (EC REP) for Medical Device Regulatory Issues

So you're ready to export to Europe. You've tackled the myriad tasks associated with packaging, mark...
Software as a Medical Device: Definitions, Examples & Regulatory Framework - Featured Image

Software as a Medical Device: Definitions, Examples & Regulatory Framework

Software as a Medical Device (SaMD) is a technology with limitless possibilities. In the hands of ta...
Quality Insights from a 40+ Year Veteran of the Medical Device Industry - Featured Image

Quality Insights from a 40+ Year Veteran of the Medical Device Industry

In this episode of the Global Medical Device Podcast, Jon Speer talks to Herschel “Buzz” Peddicord, ...
European Authorized Representative for Medical Device Companies - Featured Image

European Authorized Representative for Medical Device Companies

ANSWERED ON THIS PAGE: What are the responsibilities of an EU Authorized Representative (EC REP)? Ca...
3 FAQ about CE Marking Medical Device Manufacturers Want to Know - Featured Image

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...
What is a Class 1 Medical Device? - Featured Image

What is a Class 1 Medical Device?

In the US, the governing body tasked with regulating the medical device market is the Food and Drug ...
What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)? - Featured Image

What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)?

Quality management is an essential part of manufacturing any product, regardless of size, complexity...
When to Throw the Least Burdensome Flag on FDA - Featured Image

When to Throw the Least Burdensome Flag on FDA

What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional infor...
What is an ISO Audit? - Featured Image

What is an ISO Audit?

When it comes to medical devices, compliance isn’t based on the honor system.
Creating a Quality Manual That Complies with ISO 13485 - Featured Image

Creating a Quality Manual That Complies with ISO 13485

An excellent quality management system (QMS) is one of the keys to bringing a safe and effective med...
Case Study: How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile - Featured Image

Case Study: How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical d...
How to Execute a Successful Product Launch - Featured Image

How to Execute a Successful Product Launch

Bringing a medical device to market can take anywhere from three to seven years, on average. The des...
Case Study: How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical - Featured Image

Case Study: How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical

“Having partners with common values is just as important as the product or services themselves.” Dan...
Greenlight Guru Opens New Global Headquarters in Downtown Indianapolis - Featured Image

Greenlight Guru Opens New Global Headquarters in Downtown Indianapolis

Fast-growing software company to host grand opening event to celebrate company’s investment in growt...
Past, Present, Future State (and World) of Quality in the Medical Device Industry - Featured Image

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Quality is a concept that is often overcomplicated in the medical device industry. With complexity c...
How Should Artificial Intelligence in Medical Devices be Regulated? - Featured Image

How Should Artificial Intelligence in Medical Devices be Regulated?

Take a close look at any global industry and you’ll find them all locked in the same race toward inn...
3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US - Featured Image

3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US

Anyone who works in the medical device industry will tell you that quality and patient care is of th...
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 use...
True Quality: Greenlight Guru consistently ranked the #1 QMS by users for three years in a row - Featured Image

True Quality: Greenlight Guru consistently ranked the #1 QMS by users for three years in a row

Greenlight Guru is proud to announce that for three years straight, we have been named the leader in...
Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc - Featured Image

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the...
What is the FDA Medical Device Registration Process? - Featured Image

What is the FDA Medical Device Registration Process?

To patients and providers, medical devices are more than a product. They serve as the conduit to bet...
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

So you need to make a change to your medical device, what now?
Top 3 Reasons for FDA 483 Observations in 2020 - Featured Image

Top 3 Reasons for FDA 483 Observations in 2020

The US Food and Drug Administration (FDA) has released the quality system inspection data for citati...
How to Use the MDSAP Companion Document - Featured Image

How to Use the MDSAP Companion Document

When people speak of bringing a medical device “to market,” the location of that market is often lef...
Addressing the 'Who, What, When' of Quality in the Medical Device Industry - Featured Image

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

There are many schools of thought when it comes to the 'who, what, and when' of quality management f...
3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers - Featured Image

3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers

Software as a Medical Device (SaMD) is a rapidly growing subset of the medical device industry, and ...
Goodbye EN 1041. Hello ISO 20417:2021. - Featured Image

Goodbye EN 1041. Hello ISO 20417:2021.

When you’re trying to bring a new medical device to market, it’s normal to be focused on actually bu...
Driving Medtech Innovation with Safe and Effective Medical Devices - Featured Image

Driving Medtech Innovation with Safe and Effective Medical Devices

In the medical device industry, innovation is a complicated subject.
Meet a Guru: Maryann Mitchell - Featured Image

Meet a Guru: Maryann Mitchell

What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru e...
5 Biggest Quality Mistakes (And How You Can Avoid Making Them) - Featured Image

5 Biggest Quality Mistakes (And How You Can Avoid Making Them)

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality m...
Why Storytelling Matters for Medical Device Companies - Featured Image

Why Storytelling Matters for Medical Device Companies

Medical device companies need to tell slightly different versions of their stories depending on the ...
CEO of High-Growth Software Company Places Top 10 in the World in Elite Rowing Competition - Featured Image

CEO of High-Growth Software Company Places Top 10 in the World in Elite Rowing Competition

David DeRam, CEO of Greenlight Guru, credits mindset techniques such as autohypnosis for both rowing...
5 Postmarket Surveillance System Musts for Every EU Manufacturer - Featured Image

5 Postmarket Surveillance System Musts for Every EU Manufacturer

Designing, developing, and getting your medical device approved and onto the market is a huge accomp...
A Breakthrough Device that Aims to Prevent Osteoporosis - Featured Image

A Breakthrough Device that Aims to Prevent Osteoporosis

Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone ...
3 Things Med Device Startups Must Do When Implementing a QMS - Featured Image

3 Things Med Device Startups Must Do When Implementing a QMS

I often hear early-stage medical device companies say they’re not ready for a quality management sys...
First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Medical Device Success Platform - Featured Image

First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Medical Device Success Platform

Understanding FDA's New Intended Use Rule and its Implications - Featured Image

Understanding FDA's New Intended Use Rule and its Implications

FDA published a final rule, which goes into effect the first of September, to amend its “intended us...
7 Documentation Musts for All Software Device Premarket Submissions - Featured Image

7 Documentation Musts for All Software Device Premarket Submissions

As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...
Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success - Featured Image

Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success

Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare tha...
3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases - Featured Image

3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases

Too many companies still treat risk management as a “checkbox” activity.
Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification - Featured Image

Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...
eQMS in Academia: Practical Learning for Biomedical Engineering Students - Featured Image

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical devi...
Understanding the Premarket Approval (PMA) Process - Featured Image

Understanding the Premarket Approval (PMA) Process

Before any medical device can hit the US market, FDA must first evaluate the product’s potential ris...
How are Medical Devices Classified under EU MDR? - Featured Image

How are Medical Devices Classified under EU MDR?

One of the most important steps in bringing a medical device to market in the European Union (EU) is...
Tips for Running Better Management Reviews - Featured Image

Tips for Running Better Management Reviews

How efficient are your management reviews? Could improvements be made? It might be time to reevaluat...
How to Apply IEC 62304 Requirements for Medical Device Software - Featured Image

How to Apply IEC 62304 Requirements for Medical Device Software

If you’re developing a medical device that uses software, or developing SaMD (Software as a Medical ...
Understanding the FDA Medical Device Classification System - Featured Image

Understanding the FDA Medical Device Classification System

The world of medical devices is one of the most varied and complex industries around today. Innovati...
Meet a Guru: Ryan Behringer - Featured Image

Meet a Guru: Ryan Behringer

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device com...
Navigating the MedTech Cybersecurity Ecosystem - Featured Image

Navigating the MedTech Cybersecurity Ecosystem

Cybersecurity continues to be a crucial concern for medical device safety and effectiveness in the U...
Cybersecurity for Medical Devices: Best Practices from Regulatory Standards - Featured Image

Cybersecurity for Medical Devices: Best Practices from Regulatory Standards

As more and more medical devices utilizing network connection technology are developed, cybersecurit...
Choosing and Managing Your Medical Device Suppliers - Featured Image

Choosing and Managing Your Medical Device Suppliers

Managing your medical device suppliers is a core responsibility of manufacturers.
Managing Clinical Data Activities - Featured Image

Managing Clinical Data Activities

Many medical device companies experience challenges with managing clinical trials even in the most i...
Applying ISO 10993-1 to Medical Device Submission to FDA - Featured Image

Applying ISO 10993-1 to Medical Device Submission to FDA

ISO 10993-1 is the medical device industry’s globally recognized standard for biological evaluation ...
Customers Rank Greenlight Guru Leader in QMS and Medical QMS Software in G2 Grid Reports for Summer 2021 - Featured Image

Customers Rank Greenlight Guru Leader in QMS and Medical QMS Software in G2 Grid Reports for Summer 2021

Greenlight Guru is excited to announce that we have been named a leader in G2’s Summer 2021 Grid Rep...
Explaining the Role of Importer under EU MDR - Featured Image

Explaining the Role of Importer under EU MDR

What is the role of the importer, according to EU MDR? The requirements for this role have changed s...
Does My Device Labeling Comply with 21 CFR 801? - Featured Image

Does My Device Labeling Comply with 21 CFR 801?

Medical device labeling is a core requirement for getting your device onto the market.
Understanding Intended Use from ISO TR 24971:2020 - Featured Image

Understanding Intended Use from ISO TR 24971:2020

If you haven’t yet got into ISO TIR 24971:2020, there’s a fair bit to read up on.
Preparing Your Pre-Submission with the Content FDA Wants to See - Featured Image

Preparing Your Pre-Submission with the Content FDA Wants to See

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...
Centese Trades in Paper-based QMS for Medical Device Success Platform & Achieves 510(k) Clearance - Featured Image

Centese Trades in Paper-based QMS for Medical Device Success Platform & Achieves 510(k) Clearance

For many early-stage medical device companies, the default option when implementing a quality manage...
How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021 - Featured Image

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021

What can you still do to help in response to the COVID-19 pandemic? The National Institute of Biomed...
How the MDSAP Grading System Works - Featured Image

How the MDSAP Grading System Works

The Medical Device Single Audit Program (MDSAP) allows you to have a single audit of your medical de...
How New Training Partnership is Advancing Medical Device Knowledge & Professional Development - Featured Image

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development

Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device ...
Greenlight Guru Announces Medical Device HQ Partnership - Featured Image

Greenlight Guru Announces Medical Device HQ Partnership

New partnership with training experts will allow the medical device industry’s leading software plat...
Greenlight Guru Receives Strategic Growth Investment from JMI Equity - Featured Image

Greenlight Guru Receives Strategic Growth Investment from JMI Equity

New investment will allow the medical device industry’s leading software platform to rapidly expand ...
Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020 - Featured Image

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

What did FDA report as the most-cited issues during medical device inspections for the fiscal year o...
How MHRA is Regulating Medical Devices in the UK after Brexit - Featured Image

How MHRA is Regulating Medical Devices in the UK after Brexit

If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in ...
ISO 14971 Risk Management for Medical Devices: The Definitive Guide - Featured Image

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

How Mindset Training Can Help Your Team Operate at Peak Performance - Featured Image

How Mindset Training Can Help Your Team Operate at Peak Performance

Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceedi...
Top 40+ Medical Device Conferences To Attend in 2020 - Featured Image

Top 40+ Medical Device Conferences To Attend in 2020

Simply attending the right medical device conference can be a game-changer for those who work in the...
Examining the HHS Proposal for Premarket Notification Exemptions - Featured Image

Examining the HHS Proposal for Premarket Notification Exemptions

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS...
Recruiting Top Medical Device Talent in a Competitive Market - Featured Image

Recruiting Top Medical Device Talent in a Competitive Market

While robust growth in the medical device industry has seen more people coming into the field, it’s ...
Greenlight Guru Launches Global Medical Device Job Board - Featured Image

Greenlight Guru Launches Global Medical Device Job Board

Leading medical device QMS provider introduces industry-specific job board to provide companies excl...
Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead - Featured Image

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

If you love learning and want to level up your medical device industry knowledge on topics such as a...
How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation - Featured Image

How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation

Clinical investigations play an important role in your journey of bringing a medical device to marke...
Building your Brand as a Medical Device Professional - Featured Image

Building your Brand as a Medical Device Professional

Have you ever had to “sell” your brand to someone? To do this effectively, you must master the art o...
FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon? - Featured Image

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

Would things be simpler in the medical device regulatory space if there was global harmonization acr...
Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board - Featured Image

Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board

Leading medical device QMS provider establishes Regulatory Advisory Board comprised of global regula...
Understanding the Value of a Medical Device Guru - Featured Image

Understanding the Value of a Medical Device Guru

Have you ever wondered, what does a medical device guru actually do? What role do they play within G...
Meet a Guru: Etienne Nichols - Featured Image

Meet a Guru: Etienne Nichols

The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companie...
5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device - Featured Image

5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device

It doesn’t matter how great your medical device concept is—you’ll need some funding to get your idea...
What is 21 CFR 812 - Investigational Device Exemption? - Featured Image

What is 21 CFR 812 - Investigational Device Exemption?

Could your medical device qualify for an investigational device exemption (IDE)?
Meet a Guru: Laura Court - Featured Image

Meet a Guru: Laura Court

What makes Greenlight Guru unique? It’s the Guru edge⁠—a team of medical device professionals with a...
Regulatory Tips & Pointers from a Former FDA Reviewer - Featured Image

Regulatory Tips & Pointers from a Former FDA Reviewer

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamle...
Top Risk Management Tools in the Medical Device Industry - Featured Image

Top Risk Management Tools in the Medical Device Industry

The role of risk management for medical devices is not just a regulatory expectation, it’s a critica...
5 Tips to Improve your Medical Equipment Quality Assurance Activities - Featured Image

5 Tips to Improve your Medical Equipment Quality Assurance Activities

You’ve just finished designing what appears to be the perfect medical device. It accomplishes its pr...
Answer these 3 questions before developing Software as a Medical Device - Featured Image

Answer these 3 questions before developing Software as a Medical Device

Health and life science organizations are constantly striving to improve patient centricity and to o...
Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?) - Featured Image

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles...
Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program - Featured Image

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program...
How to Make Your QMS Comply with EU MDR and IVDR - Featured Image

How to Make Your QMS Comply with EU MDR and IVDR

If your company has or is looking to place medical devices on the EU market, you need to know about ...
4 Reasons to Get ISO 27001 Certification - Featured Image

4 Reasons to Get ISO 27001 Certification

The average data breach costs a company $3.86 million dollars. Perhaps worse than the financial burd...
Why is IVDR Causing Widespread Panic throughout the Medical Device Industry? - Featured Image

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many devic...
Three Tips for Designing At-Home Monitoring Devices that Deliver Actionable Information - Featured Image

Three Tips for Designing At-Home Monitoring Devices that Deliver Actionable Information

We’re all seeing it in real time: Healthcare is increasingly shifting from clinical settings to our ...
How SOLIUS Replaced Paper with eQMS to Gain ISO 13485:2016 Certification in Weeks - Featured Image

How SOLIUS Replaced Paper with eQMS to Gain ISO 13485:2016 Certification in Weeks

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...
Managing Business Risk as a Medical Device Company - Featured Image

Managing Business Risk as a Medical Device Company

It's easy to get so wrapped up in the risk management of your medical device that you forget about m...
How to Build Medical Device Usability Testing and Validation into Your Quality System - Featured Image

How to Build Medical Device Usability Testing and Validation into Your Quality System

Medical device usability testing and validation are critical tasks leading up to a medical device’s ...
Waterfall vs. Agile: Battle of the Product Development Methodologies - Featured Image

Waterfall vs. Agile: Battle of the Product Development Methodologies

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?
For the Love of Internal Auditing - Featured Image

For the Love of Internal Auditing

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me...
Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps - Featured Image

Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps

The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical ...
Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices - Featured Image

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a ...
5 Steps to Faster-to-Market, More Profitable Medical Devices - Featured Image

5 Steps to Faster-to-Market, More Profitable Medical Devices

Healthcare provider market demands are such that medical device companies often find themselves in s...
Knowing vs. Doing as Medical Device Professionals - Featured Image

Knowing vs. Doing as Medical Device Professionals

For medical device professionals, there are the “knowers” and the “doers.”
How to Structure your Medical Device Technical File - Featured Image

How to Structure your Medical Device Technical File

The medical device technical file is a must-have document for devices to be sold in the EU marketpla...
Greenlight Guru Named Premier QMS Software for NIH RADx Initiative - Featured Image

Greenlight Guru Named Premier QMS Software for NIH RADx Initiative

MDQMS leader to support national COVID-19 diagnostics program through purpose-built solutions.
Pivoting Operations to Meet PPE Demand during Pandemic - Featured Image

Pivoting Operations to Meet PPE Demand during Pandemic

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, ar...
Pros & Cons of Being a Physician turned MedTech Inventor - Featured Image

Pros & Cons of Being a Physician turned MedTech Inventor

Do you fear needles and the associated pain? No one understands this fear more than physicians who s...
What is a Quality Agreement for Medical Devices? - Featured Image

What is a Quality Agreement for Medical Devices?

There’s a good chance you’re not manufacturing your own medical device—contract medical device manuf...
3 Systems of Risk for Medical Devices from FDA - Featured Image

3 Systems of Risk for Medical Devices from FDA

Why does FDA have three systems in place to address and handle risk for medical devices? Each system...
Quality Management for IVD Devices vs Medical Devices - Featured Image

Quality Management for IVD Devices vs Medical Devices

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD...
Am I Complying with FDA Medical Device Labeling Requirements? - Featured Image

Am I Complying with FDA Medical Device Labeling Requirements?

Medical device labeling requirements are a key part of getting your device to market.
Understanding the Investigational Device Exemption (IDE) Process - Featured Image

Understanding the Investigational Device Exemption (IDE) Process

Does your medical device qualify for an investigational device exemption (IDE)? What does this proce...
Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry - Featured Image

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself?...
How to Use the FDA ESG (Electronic Submissions Gateway) - Featured Image

How to Use the FDA ESG (Electronic Submissions Gateway)

The most competitive medical device companies embrace technology as a tool to make systems and proce...
Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients - Featured Image

Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

Why is design, manufacturing, quality, and culture so important in the medical device industry?
What is the Safer Technologies Program (STeP) and Can Your Device Use It? - Featured Image

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices f...
3 Valuable Outcomes of a Culture of Quality - Featured Image

3 Valuable Outcomes of a Culture of Quality

Do you consider your medical device company to have a culture of quality?
Meet a Guru: Sara Adams - Featured Image

Meet a Guru: Sara Adams

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical d...
Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS - Featured Image

Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

The IVD market reaches into all corners of the world, and for many device companies, this niche prod...
Why the PMA Process is so Dreaded by Manufacturers in the US Market - Featured Image

Why the PMA Process is so Dreaded by Manufacturers in the US Market

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that h...
What is a Traceability Matrix and How Do I Create One for My Medical Device? - Featured Image

What is a Traceability Matrix and How Do I Create One for My Medical Device?

You’ve probably heard a traceability matrix is something you need as part of your medical device QMS...
Building a Startup in the MedTech Industry - Featured Image

Building a Startup in the MedTech Industry

What does it take to build a successful MedTech startup? It’s a multi-million dollar question and th...
Meet a Guru: Karen Schuyler - Featured Image

Meet a Guru: Karen Schuyler

What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with a ton...
Greenlight Guru Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community - Featured Image

Greenlight Guru Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community

Greenlight Guru Academy will educate and train medical device professionals on everything they need ...
How to Demonstrate Substantial Equivalence in 5 Easy Steps - Featured Image

How to Demonstrate Substantial Equivalence in 5 Easy Steps

If you’re taking the 510(k) route to market for your medical device, demonstrating substantial equiv...
Visualizing a Medical Device through Illustrations, Animations, and other Artwork - Featured Image

Visualizing a Medical Device through Illustrations, Animations, and other Artwork

Imagine using medical illustrations, animations, and other types of artwork to tell the story of a m...
Everything you Need to Know about SaMD from an FDA Perspective - Featured Image

Everything you Need to Know about SaMD from an FDA Perspective

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are i...
How to Use Voluntary Consensus Standards to your Strategic Advantage - Featured Image

How to Use Voluntary Consensus Standards to your Strategic Advantage

If we were to say that it’s okay if you don’t follow all relevant standards when you develop your me...
Preparing for Remote and On-Site Inspections and Audits - Featured Image

Preparing for Remote and On-Site Inspections and Audits

How can medical device companies be better prepared for remote and on-site inspections and audits? P...
How does EU MDR impact your Quality Management System? - Featured Image

How does EU MDR impact your Quality Management System?

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challe...
Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device? - Featured Image

Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?

If your medical device falls under premarket submission criteria, there are three types of 510(k) th...
Virtual Auditing in a Post-COVID World of Digital Compliance - Featured Image

Virtual Auditing in a Post-COVID World of Digital Compliance

What do auditing and compliance protocols look like during a pandemic? Medical device companies cont...
Why a Visual QMS is So Important for Your Medical Device Company - Featured Image

Why a Visual QMS is So Important for Your Medical Device Company

How valuable would it be to have a visual representation of your entire QMS and all of its functioni...
Case Study: How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS - Featured Image

Case Study: How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS

While the current health crisis has served as a catalyst for innovation for medical device companies...
5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes - Featured Image

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

Your internal quality audits should be much more than a “checkbox” requirement on your compliance to...
Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View - Featured Image

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

Keeping a constant pulse on current medical device industry standards for risk management, like ISO ...
How to Create a Quality Management Plan - Featured Image

How to Create a Quality Management Plan

Technically speaking, you can launch a product without a quality management plan—but most of your go...
Greenlight Guru Announces True Quality Summit Series: EU MDR & IVDR - Featured Image

Greenlight Guru Announces True Quality Summit Series: EU MDR & IVDR

Leading MDQMS provider combines global regulatory leadership with original research data to provide ...
Ultimate Guide to Training Management for Medical Device Companies - Featured Image

Ultimate Guide to Training Management for Medical Device Companies

Prioritizing Medical Device Reimbursement During Product Development - Featured Image

Prioritizing Medical Device Reimbursement During Product Development

Medical device reimbursement is a key consideration that must be well researched, understood, and ma...
Understanding ISO 13485 Training and Competency Requirements - Featured Image

Understanding ISO 13485 Training and Competency Requirements

Are the employees in your medical device company meeting the training and competency requirements of...
5 Key Principles of Total Quality Management - Featured Image

5 Key Principles of Total Quality Management

It's easy to think of quality as a niche responsibility, requiring only the involvement of those wor...
5 Actionable Lessons Learned from the RADx Initiative by NIH - Featured Image

5 Actionable Lessons Learned from the RADx Initiative by NIH

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Hea...
How Does a Medical Device Quality Management System Differ from other QMS Tools? - Featured Image

How Does a Medical Device Quality Management System Differ from other QMS Tools?

Establishing a more efficient and effective quality management system (QMS) has been a recurring que...
Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means - Featured Image

Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means

Are you gearing up to submit a 510(k)? If so, you need to have a thorough understanding of what “sub...
Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

In an industry that is ever-evolving, change is inevitable.
What are the Strategic Priorities for CDRH in 2021? - Featured Image

What are the Strategic Priorities for CDRH in 2021?

What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) a...
Change Management Process Explained in 6 Easy Steps (+ free template) - Featured Image

Change Management Process Explained in 6 Easy Steps (+ free template)

In Prosci’s research, participants were six times more likely to meet project goals by following an ...
Say Hello to Predictive Quality: Greenlight Guru Introduces Intelligent Document Management powered by Halo℠ - Featured Image

Say Hello to Predictive Quality: Greenlight Guru Introduces Intelligent Document Management powered by Halo℠

Today’s medical device companies are moving, changing, and adapting at an incredibly rapid pace. 
Greenlight Guru Launches Halo℠ For Change Management, World’s First AI & ML Recommendation Engine for Medical Device Quality - Featured Image

Greenlight Guru Launches Halo℠ For Change Management, World’s First AI & ML Recommendation Engine for Medical Device Quality

New predictive recommendation engine transforms the way medical device companies are able to discove...
Understanding and Handling Different Types of Feedback - Featured Image

Understanding and Handling Different Types of Feedback

What’s the relationship between product feedback, complaints, and adverse events? 
How to Use the De Novo Pathway for your Medical Device - Featured Image

How to Use the De Novo Pathway for your Medical Device

Is the De Novo regulatory pathway a viable option to get your medical device to market?
Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape - Featured Image

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device ind...
Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster - Featured Image

Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster

Customers benefit from expert advice to lower development costs and save time identifying the right ...
Understanding Change Management and Change Control in the Medical Device Industry - Featured Image

Understanding Change Management and Change Control in the Medical Device Industry

Change is inevitable in the medical device industry. Innovative device companies are at the constant...
Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry - Featured Image

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may b...
Most Popular Medical Device Content in 2020 from Greenlight Guru - Featured Image

Most Popular Medical Device Content in 2020 from Greenlight Guru

Thank you for helping make 2020 another exciting and record-breaking year for Greenlight Guru!
Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near - Featured Image

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficu...
6 Benefits of the Best 21 CFR Part 11 Compliant Software - Featured Image

6 Benefits of the Best 21 CFR Part 11 Compliant Software

Nearly every medical device company is subject to software validation requirements, regardless of wh...
How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes? - Featured Image

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related...
2021 State of Medical Device Quality Management and Product Development Benchmark Report - Featured Image

2021 State of Medical Device Quality Management and Product Development Benchmark Report

Findings of a 2021 industry benchmark survey reveal internal divides within organizations are making...
Why SaMD Companies Should be Leveraging Pre-Submissions to FDA - Featured Image

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device ind...
What is the True Cost of Poor Quality for Your Medical Device Company? (Free Infographic) - Featured Image

What is the True Cost of Poor Quality for Your Medical Device Company? (Free Infographic)

For a lot of medical device companies, quality management can be a vexing issue. How much is enough?...
What Goes into Designing Devices for Military and Emergency Applications? - Featured Image

What Goes into Designing Devices for Military and Emergency Applications?

There’s one niche market within the device industry that rarely gets the attention it deserves: prod...
12 Medical Device Experts Offer Best Tips for How to Succeed in 2021 - Featured Image

12 Medical Device Experts Offer Best Tips for How to Succeed in 2021

How will COVID-19, new regulatory programs and changes, and technological advancements impact your m...
Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices - Featured Image

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device? - Featured Image

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Some sources claim that one-third of your product development project should be spent on defining go...
Top 100 Medical Device Startups with Most Money Raised in 2020 (Free Chart) - Featured Image

Top 100 Medical Device Startups with Most Money Raised in 2020 (Free Chart)

The first half of 2020 brought record-breaking investment totals for health care companies, accordin...
Streamline the right training, for the right people, at the right time. Introducing Greenlight Guru Training Management - Featured Image

Streamline the right training, for the right people, at the right time. Introducing Greenlight Guru Training Management

When you talk, we listen.
Greenlight Guru Introduces Training Management to Simplify Regulatory Compliance and Streamline the Employee Training Process - Featured Image

Greenlight Guru Introduces Training Management to Simplify Regulatory Compliance and Streamline the Employee Training Process

New dedicated workspace and capabilities ensures the right training for the right people at the righ...
Positive and Negative Impacts of EUA on the Medical Device Industry - Featured Image

Positive and Negative Impacts of EUA on the Medical Device Industry

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly uti...
Developing Pediatric Medical Devices: An Innovative Approach - Featured Image

Developing Pediatric Medical Devices: An Innovative Approach

The design and development of pediatric medical devices continue to be a challenging field.
Greenlight Guru Announces The 2021 State of Medical Device Virtual Summit - Featured Image

Greenlight Guru Announces The 2021 State of Medical Device Virtual Summit

Leading MDQMS provider powers the conversation around the impacts of COVID-19 and other industry top...
Medical Device Biocompatibility 101 - Featured Image

Medical Device Biocompatibility 101

Medical device biocompatibility can be confusing, challenging, even frustrating for device professio...
Why Biocompatibility Should be Addressed by Every Medical Device Company - Featured Image

Why Biocompatibility Should be Addressed by Every Medical Device Company

Should your medical device company address biocompatibility? The short answer is, yes. Every single ...
Everything You Need to Know about Human Factors Engineering for Your Medical Device - Featured Image

Everything You Need to Know about Human Factors Engineering for Your Medical Device

Human factors are a key part of medical device development and the sooner they’re addressed in the d...
Meet a Guru: Erica Loring - Featured Image

Meet a Guru: Erica Loring

What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with decad...
The Ultimate Internal Audit Checklist Every Medical Device Company Needs - Featured Image

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

It was nothing more than a checklist that saved $175 million and 1,500 lives.
Free Complaint Template for Medical Devices - Featured Image

Free Complaint Template for Medical Devices

One of the major post-market responsibilities of medical device companies is handling customer compl...
Free Template: Nonconformance Process for your Medical Device - Featured Image

Free Template: Nonconformance Process for your Medical Device

Eventually, every quality professional is going to have to deal with nonconformance. In the medical ...
Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events - Featured Image

Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events

New capability automates the quality event process through customized templates that increase effici...
A Free CAPA Template for the Medical Device Industry - Featured Image

A Free CAPA Template for the Medical Device Industry

If you’re a medical device professional, you’ve likely heard the acronym “CAPA” before. For those wh...
23 Must-haves for your Product Requirements Document (Free Checklist + Guide) - Featured Image

23 Must-haves for your Product Requirements Document (Free Checklist + Guide)

With the rapidly accelerating pace of innovation in the medical device arena, the procedures and pra...
How to Write a Nonconformance Report - Featured Image

How to Write a Nonconformance Report

Nonconformance is a word no quality manager wants to hear.
What is a Multiple Function Device? - Featured Image

What is a Multiple Function Device?

What is a multiple function device? From a high level, it’s a product with at least one portion that...
3 Reasons Why Closed-Loop Traceability is a QMS Must - Featured Image

3 Reasons Why Closed-Loop Traceability is a QMS Must

There is a growing expectation in the medical device industry of manufacturers to demonstrate closed...
Greenlight Guru Launches Visualize to Redefine the Medical Device Industry’s Approach to Closed-Loop Traceability - Featured Image

Greenlight Guru Launches Visualize to Redefine the Medical Device Industry’s Approach to Closed-Loop Traceability

New machine learning powered capabilities provide device makers with instant visibility into the con...
Introducing Greenlight Guru Visualize: Quality at a Bird’s Eye View - Featured Image

Introducing Greenlight Guru Visualize: Quality at a Bird’s Eye View

Most people are visual learners. In fact, it has been reported that visuals can improve learning by ...
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...
Challenges related to Home Use Devices - Featured Image

Challenges related to Home Use Devices

What could go wrong as more medical device products are used at home and in similar non-traditional ...
Quality Assurance vs. Quality Control in the Medical Device Industry - Featured Image

Quality Assurance vs. Quality Control in the Medical Device Industry

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...
Submitting a 510(k) using FDA's Safety and Performance Based Pathway - Featured Image

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Specia...
519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement - Featured Image

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

In the medical device industry, there’s a lot outside of our control. The market shifts. New, innova...
How Jon Speer Met His Most Frequent Guest: Mike Drues - Featured Image

How Jon Speer Met His Most Frequent Guest: Mike Drues

Reminiscing about past and present lessons learned from listening to conversations with this show’s ...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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