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How to Build a Medical Device Business Case in 5 Easy Steps - Featured Image

How to Build a Medical Device Business Case in 5 Easy Steps

In business, so much of success depends on timing. A product launches too early and is misunderstood...
Demystifying the De Novo Process - Featured Image

Demystifying the De Novo Process

How do you navigate the De Novo process for your medical device? When do you decide to go that route...
Greenlight Guru Earns 2022 TrustRadius Top Rated Software Award - Featured Image

Greenlight Guru Earns 2022 TrustRadius Top Rated Software Award

Greenlight Guru is thrilled to share our selection as one of the TrustRadius Top Rated products of 2...
Challenges for Regulatory Submission: EU vs. US - Featured Image

Challenges for Regulatory Submission: EU vs. US

What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing w...
8 Questions That Define Your Medical Device User Needs - Featured Image

8 Questions That Define Your Medical Device User Needs

When people talk about design controls, they often place a lot of emphasis on design inputs and outp...
Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance - Featured Image

Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance

A Performance Evaluation (PE) is required for any in vitro diagnostic device (IVD) that a manufactur...
From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE - Featured Image

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Have you ever played the game, Operation? The patient’s nose would light up and buzz if your tweezer...
30/60/90 Day Plan to Making an Impact as a New QA/RA Manager - Featured Image

30/60/90 Day Plan to Making an Impact as a New QA/RA Manager

Starting a new job is always a little stressful. But when you’re a new QA/RA Manager, there’s even m...
The Future of Cybersecurity - Featured Image

The Future of Cybersecurity

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers nee...
Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities - Featured Image

Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities

The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipul...
Achieving Operational Readiness through Good Project Management - Featured Image

Achieving Operational Readiness through Good Project Management

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Patrick Hayes, Associ...
3 Tips for Planning a Successful Product Development Project for Your Medical Device - Featured Image

3 Tips for Planning a Successful Product Development Project for Your Medical Device

If you’ve ever been involved in the design and development of a medical device, you know just how co...
Bridging the Gap between Medical Devices and Clinical Data - Featured Image

Bridging the Gap between Medical Devices and Clinical Data

Selling a medical device in the EU? Understanding the importance of clinical data and what's require...
How to Make the Most of True Quality 2022 - Featured Image

How to Make the Most of True Quality 2022

True Quality 2022 is a one-of-a-kind MedTech conference focused around the theme of quality and desi...
Explaining UDI Requirements for GUDID and EUDAMED - Featured Image

Explaining UDI Requirements for GUDID and EUDAMED

Recent numbers from the World Health Organization indicate there are at least 2 million different ty...
Ultimate Guide to Clinical Evaluation of a Medical Device in the EU - Featured Image

Ultimate Guide to Clinical Evaluation of a Medical Device in the EU

Navigating the Medical Device Single Audit Program (MDSAP) - Featured Image

Navigating the Medical Device Single Audit Program (MDSAP)

Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory require...
30/60/90 Day Plan to Making an Impact as a Product Development Engineer - Featured Image

30/60/90 Day Plan to Making an Impact as a Product Development Engineer

To say product development engineers are important to medical device development would be the unders...
3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
Bringing Augmented Reality MedTech to Market - Featured Image

Bringing Augmented Reality MedTech to Market

Today’s innovative medical technology is more like a video game and makes a minimally invasive ablat...
How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (Part 4 of 4) - Featured Image

How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (Part 4 of 4)

If you plan on selling a medical device in the European Union, then you should plan on writing a cli...
Performing Data Analysis for Your Medical Device’s Clinical Evaluation (Part 3 of 4) - Featured Image

Performing Data Analysis for Your Medical Device’s Clinical Evaluation (Part 3 of 4)

All of your hard work has been leading up to this. So far in the clinical evaluation process, you’ve...
Making Your Informational Meetings with FDA Valuable & Worthwhile - Featured Image

Making Your Informational Meetings with FDA Valuable & Worthwhile

What are informational meetings with the FDA, why should you schedule them, and how should they be c...
Everything You Need to Know About Root Cause Analysis - Featured Image

Everything You Need to Know About Root Cause Analysis

At some point, every medical device company will encounter an issue that requires an internal invest...
The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data (Part 2 of 4) - Featured Image

The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data (Part 2 of 4)

A successful clinical evaluation hinges on your ability to find and appraise the data you’ll need to...
Greenlight Guru Consistently Ranked as a Trusted Partner for Leading Medical Device Companies - Featured Image

Greenlight Guru Consistently Ranked as a Trusted Partner for Leading Medical Device Companies

Greenlight Guru is proud to announce that it has been selected - by users - as the leading QMS for t...
Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs - Featured Image

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

For many new medical device professionals a bill of materials (BOM) may feel like a big black box. W...
Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency (Part 1 of 4) - Featured Image

Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency (Part 1 of 4)

To obtain a CE marking and market your medical device in the EU, you’ll first need to perform a clin...
4 Problems (and Solutions) for the Medical Device Supply Chain - Featured Image

4 Problems (and Solutions) for the Medical Device Supply Chain

If you had told me three years ago that supply chain economics and logistics would become a popular ...
QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices - Featured Image

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the in...
Understanding Technical Documentation in EU Regulations - Featured Image

Understanding Technical Documentation in EU Regulations

Generally speaking, technical documentation is the compilation of documents that explains how a prod...
Let The Document Tell The Story: Document Management Best Practices - Featured Image

Let The Document Tell The Story: Document Management Best Practices

Good stories follow a 3-act structure: Act 1: Set up Act 2: Conflict Act 3: Resolution “Thanks a lot...
How Medical Device Intellectual Property Protection Varies by Sector - Featured Image

How Medical Device Intellectual Property Protection Varies by Sector

When developing a product in the medical device space, how does intellectual property (IP) protectio...
QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies - Featured Image

QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...
Human Factors & Risk Management: What's Needed & Why? - Featured Image

Human Factors & Risk Management: What's Needed & Why?

Don’t give up on risk management. It’s the backbone of the product development lifecycle and human f...
Your Device is Non-Significant Risk: Now What? - Featured Image

Your Device is Non-Significant Risk: Now What?

If you need to conduct a clinical investigation of your device before it has received market approva...
The Five Themes of True Quality 2022 - Featured Image

The Five Themes of True Quality 2022

In the medical device world, inspiration and excitement are rarely hard to come by - you just have t...
Greenlight Guru and Lexisnexis® Reed Tech Announce Strategic Alliance to Guide Customers to Market Faster - Featured Image

Greenlight Guru and Lexisnexis® Reed Tech Announce Strategic Alliance to Guide Customers to Market Faster

Greenlight Guru has teamed up with LexisNexis® Reed Tech, the leader in regulatory product data subm...
What are the Opportunities for Improvement (OFI) for Quality? - Featured Image

What are the Opportunities for Improvement (OFI) for Quality?

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportuniti...
Software Bill of Materials: What to Know About SBOMs for Medical Devices - Featured Image

Software Bill of Materials: What to Know About SBOMs for Medical Devices

On May 12, 2021, President Biden signed the Executive Order On Improving the Nation’s Cybersecurity....
Survey Finds Fewer Than 3% of Pre-Market Medical Device Companies Are Very Effective at Measuring the Results of Quality Initiatives - Featured Image

Survey Finds Fewer Than 3% of Pre-Market Medical Device Companies Are Very Effective at Measuring the Results of Quality Initiatives

Findings from the Greenlight Guru 2022 Medical Device industry benchmark survey reveal a need to foc...
Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph - Featured Image

Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

They say eyes are windows to the soul; that studying someone’s gaze can reveal their innermost emoti...
What is the Best Way to Structure a Risk Management File? - Featured Image

What is the Best Way to Structure a Risk Management File?

The medical device risk management process relies heavily on the use of documentation. Whether the a...
How to Convince Your Boss to Send You to True Quality 2022 - Featured Image

How to Convince Your Boss to Send You to True Quality 2022

True Quality 2022 is a must-attend experience for medical device professionals at early-stage compan...
Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR - Featured Image

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

The European Union Medical Device Regulation (EU MDR) and European Union In Vitro Diagnostic Regulat...
Design vs. Utility Patents: Choosing the Right One for Your Device - Featured Image

Design vs. Utility Patents: Choosing the Right One for Your Device

If you go through the rigors of designing and developing a medical device, it only makes sense that ...
Achieve Connected & Continuous Product Development: Introducing Greenlight Guru Products. - Featured Image

Achieve Connected & Continuous Product Development: Introducing Greenlight Guru Products.

 
Greenlight Guru Expands Solution to Further Integrate Quality and Product Development Activities - Featured Image

Greenlight Guru Expands Solution to Further Integrate Quality and Product Development Activities

New functionality empowers users to build bills of materials (BOMs), manage product families, and st...
How to Select a Contract Manufacturer - Featured Image

How to Select a Contract Manufacturer

What is the best way for medical device professionals, early-stage, and established companies to sel...
What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers...
10 Reasons to Attend True Quality 2022 - Featured Image

10 Reasons to Attend True Quality 2022

Here at Greenlight Guru, we’ve long since been a champion of quality over everything.
A Regulatory Gap Analysis of FDA's Systems & Policies - Featured Image

A Regulatory Gap Analysis of FDA's Systems & Policies

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improv...
What You Need to Know About True Quality 2022 - Featured Image

What You Need to Know About True Quality 2022

Innovative medical device companies often find themselves in a no-man’s land when it comes to findin...
Greenlight Guru Announces True Quality 2022, Inaugural Conference for the Medical Device Industry - Featured Image

Greenlight Guru Announces True Quality 2022, Inaugural Conference for the Medical Device Industry

True Quality 2022 will provide curated educational and networking experiences for medical device pro...
Bill of Materials (BOM) for Medical Devices: Everything You Need To Know - Featured Image

Bill of Materials (BOM) for Medical Devices: Everything You Need To Know

When it comes to complexity, medical devices run the gamut.
Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat - Featured Image

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat

How can early-stage medical device companies improve product quality, increase creativity, get to ma...
Bringing Innovation and Quality to the Forefront | Greenlight Guru Acquires CanvasGT - Featured Image

Bringing Innovation and Quality to the Forefront | Greenlight Guru Acquires CanvasGT

Greenlight Guru Acquires CanvasGT to Dramatically Enhance Iterative Design Planning for Medical Devi...
Greenlight Guru Acquires Visual Medical Design Collaboration Solution CanvasGT - Featured Image

Greenlight Guru Acquires Visual Medical Design Collaboration Solution CanvasGT

New acquisition will allow the medical device industry’s leading software platform to provide extend...
3 Medical Device Security Challenges (and Solutions) - Featured Image

3 Medical Device Security Challenges (and Solutions)

Technological innovations in and around the medical device industry have made it possible for compan...
How Do FDA Medical Device Recalls Work? - Featured Image

How Do FDA Medical Device Recalls Work?

For medical device companies, few things are as valuable as the public’s trust.
Tips For Being Prepared Post-EUA (Emergency Use Authorization) - Featured Image

Tips For Being Prepared Post-EUA (Emergency Use Authorization)

Does your company have products that were granted emergency use authorization to get to market? Assu...
Understanding the Quality Control Process in Medical Device Manufacturing - Featured Image

Understanding the Quality Control Process in Medical Device Manufacturing

The goal of any medical device is to improve the lives of its users.
ISO 11137: An Introduction to Gamma Sterilization Validation - Featured Image

ISO 11137: An Introduction to Gamma Sterilization Validation

For many medical device companies, sterilization is one of the final hurdles they have to clear befo...
Understanding the UDI System for Medical Devices - Featured Image

Understanding the UDI System for Medical Devices

Do you understand how the Unique Device Identification (UDI) system in the medical device industry w...
Best Practices for an Effective Medical Device Design Transfer Process - Featured Image

Best Practices for an Effective Medical Device Design Transfer Process

If you’re looking for information on design controls and product development, you can find a practic...
Top 40+ Medical Device Conferences To Attend in 2022 (Virtual + In Person) - Featured Image

Top 40+ Medical Device Conferences To Attend in 2022 (Virtual + In Person)

Attending the right conference can be a game-changer for those working in the medical device industr...
Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know - Featured Image

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

Your device history record (DHR) is one of the final forms of documentation you’ll need before your ...
Most Popular Medical Device Content in 2021 - Featured Image

Most Popular Medical Device Content in 2021

At Greenlight Guru, we’ll never forget 2021. It was a big year of growth for us, our customers, and ...
Cytotoxicity Testing: Ensuring the Biocompatibility of Your Medical Device - Featured Image

Cytotoxicity Testing: Ensuring the Biocompatibility of Your Medical Device

Biocompatibility testing is one of the fundamental means of ensuring medical devices are safe for pa...
Shaking Things Up: What's Next for the Global Medical Device Podcast - Featured Image

Shaking Things Up: What's Next for the Global Medical Device Podcast

Global Medical Device Podcast host and founder of Greenlight Guru, Jon Speer, always says he has the...
Customers Rank Greenlight Guru As Leading QMS Software on G2 For 13th Consecutive Quarter - Featured Image

Customers Rank Greenlight Guru As Leading QMS Software on G2 For 13th Consecutive Quarter

Greenlight Guru is proud to announce that it has been selected - by users - as the leading QMS for t...
Understanding Product Realization under ISO 13485 - Featured Image

Understanding Product Realization under ISO 13485

Medical devices always begin the same way: as an idea. And while ideas are an invaluable resource, t...
IQ, OQ, PQ: A Quick Guide to Process Validation - Featured Image

IQ, OQ, PQ: A Quick Guide to Process Validation

In the medical device industry, even one failure in a process can lead to devastating consequences f...
UDI: Everything You Need to Know About Unique Device Identifiers for the FDA - Featured Image

UDI: Everything You Need to Know About Unique Device Identifiers for the FDA

Every aspect of the medical device industry needs to be built on the highest standards for quality a...
What Does the IDE Application Process Involve? - Featured Image

What Does the IDE Application Process Involve?

When medical device manufacturers hope to bring a new and perhaps revolutionary medical device to ma...
How Augmented Reality (AR) is Revolutionizing Healthcare - Featured Image

How Augmented Reality (AR) is Revolutionizing Healthcare

Technology can accelerate the transformation of healthcare to improve health, quality of life, safet...
Tips for Virtual Audits Your Medical Device Company Can Implement Today - Featured Image

Tips for Virtual Audits Your Medical Device Company Can Implement Today

Auditing medical device manufacturers is one of the most important aspects of ensuring quality stand...
Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered - Featured Image

Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered

There are plenty of new requirements to be aware of in both the EU Medical Device Regulation (EU MDR...
ISO 11607: A Primer on Packaging for Terminally Sterilized Medical Devices - Featured Image

ISO 11607: A Primer on Packaging for Terminally Sterilized Medical Devices

For many medical devices, sterilization is the final step in the manufacturing process before they’r...
Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care - Featured Image

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care

At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — ...
Preparing for EUDAMED - Europe’s Medical Device Database - Featured Image

Preparing for EUDAMED - Europe’s Medical Device Database

In 2017, the European Commission (EC) released two new regulations, one specific to medical devices ...
Ultimate List of ISO Standards for Medical Devices - Featured Image

Ultimate List of ISO Standards for Medical Devices

The International Standardization Organization (ISO) is an independent, non-governmental organizatio...
Why Usability Matters - Featured Image

Why Usability Matters

Usability is essential. If you design something, anything used by humans, it needs to be designed fo...
Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices - Featured Image

Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices

In the European Union, in vitro diagnostic (IVD) devices are governed by a specific set of regulatio...
Engineering Change Order: The Role it Plays in the Change Management Process - Featured Image

Engineering Change Order: The Role it Plays in the Change Management Process

Change is just part of life for medical device companies. No device makes it to market without quite...
Explaining IVDR Classification for In Vitro Medical Devices - Featured Image

Explaining IVDR Classification for In Vitro Medical Devices

The In Vitro Diagnostic Regulation (IVDR), which concerns in vitro diagnostic medical devices in the...
A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology - Featured Image

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology

Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transfo...
Greenlight Guru Launches Guru Assist, On-Demand Lifeline to Medical Device Experts - Featured Image

Greenlight Guru Launches Guru Assist, On-Demand Lifeline to Medical Device Experts

New on-demand assistance functionality offers a flexible way to leverage expert medical device suppo...
ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide - Featured Image

ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide

Once a medical device has been designed, developed, and manufactured to specifications, it may feel ...
How to Approach Corrective Action Requests with Medical Device Suppliers - Featured Image

How to Approach Corrective Action Requests with Medical Device Suppliers

For medical device manufacturers, finding success means setting ourselves up for success with repeat...
The Growing Internet of Medical Things (IoMT) & its Implications for Medical Device Manufacturers - Featured Image

The Growing Internet of Medical Things (IoMT) & its Implications for Medical Device Manufacturers

The internet of things (IoT) is a blanket term used to describe the billions of connected objects an...
3 Non-negotiables for Managing Business Risk as a Medical Device Company - Featured Image

3 Non-negotiables for Managing Business Risk as a Medical Device Company

How seriously do you take risk management? This may seem like an inane question, especially for a pr...
What are the Top Compliance Issues Plaguing Medical Device Manufacturers? - Featured Image

What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

Medical device companies must comply with a list of strict requirements throughout the duration of t...
What are the SaMD Requirements from FDA? - Featured Image

What are the SaMD Requirements from FDA?

The market for software as a medical device (SaMD) is growing rapidly as more companies see the poss...
Greenlight Guru and Formlabs Partner to Mitigate Risk and Accelerate Product Development in order to Improve Patient Outcomes - Featured Image

Greenlight Guru and Formlabs Partner to Mitigate Risk and Accelerate Product Development in order to Improve Patient Outcomes

Customers benefit from leveraging industry medical specific eQMS and 3D printing
Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry - Featured Image

Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry

To ensure quality and mitigate the risk of subjectivity or bias, the European and Canadian medical d...
Failure Mode Effects Analysis: What Is It & When Should You Use It? - Featured Image

Failure Mode Effects Analysis: What Is It & When Should You Use It?

Failure mode effects analysis (FMEA) is one of the best-known risk management tools within engineeri...
Setting the Record Straight on Usability & Human Factors - Featured Image

Setting the Record Straight on Usability & Human Factors

What is usability? Human factors? Are they one and the same or different in the medical device indus...
What is a Class 2 Medical Device in the US? - Featured Image

What is a Class 2 Medical Device in the US?

The goal of anyone involved in medical devices is simple: produce high quality products that improve...
25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition - Featured Image

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

In this article you will find a comprehensive list of the most frequently asked questions from parti...
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...
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...

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