Medical Device Quality, Regulatory and Product Development Blog

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

By Etienne Nichols on May 16, 2022

In business, so much of success depends on timing. A product launches too early and is misunderstood...

Demystifying the De Novo Process

By Nick Tippmann on May 12, 2022

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

By Nick Tippmann on May 11, 2022

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

By Nick Tippmann on May 6, 2022

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

By Laura Court on May 6, 2022

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

By Etienne Nichols on May 5, 2022

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

By Nick Tippmann on May 4, 2022

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

By Etienne Nichols on May 1, 2022

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

By Nick Tippmann on April 29, 2022

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

By Etienne Nichols on April 28, 2022

The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipul...

Achieving Operational Readiness through Good Project Management

By Nick Tippmann on April 27, 2022

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

By Etienne Nichols on April 24, 2022

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

By Nick Tippmann on April 20, 2022

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

By Kennedy Gennari on April 18, 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

By Etienne Nichols on April 17, 2022

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

By Niki Price on April 15, 2022

Navigating the Medical Device Single Audit Program (MDSAP)

By Nick Tippmann on April 13, 2022

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

By Etienne Nichols on April 8, 2022

To say product development engineers are important to medical device development would be the unders...

3 Common Misconceptions About Medical Device Packaging

By Etienne Nichols on April 8, 2022

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

By Nick Tippmann on April 6, 2022

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)

By Niki Price on April 3, 2022

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)

By Niki Price on April 1, 2022

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

By Nick Tippmann on March 30, 2022

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

By Brittney McIver on March 27, 2022

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)

By Niki Price on March 25, 2022

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

By Nick Tippmann on March 24, 2022

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

By Nick Tippmann on March 23, 2022

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)

By Niki Price on March 20, 2022

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

By Taylor Brown on March 18, 2022

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

By Nick Tippmann on March 16, 2022

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

By Laura Court on March 13, 2022

Generally speaking, technical documentation is the compilation of documents that explains how a prod...

Let The Document Tell The Story: Document Management Best Practices

By Etienne Nichols on March 11, 2022

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

By Nick Tippmann on March 9, 2022

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

By Etienne Nichols on March 2, 2022

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...

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

By Nick Tippmann on March 2, 2022

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?

By Laura Court on February 27, 2022

If you need to conduct a clinical investigation of your device before it has received market approva...

The Five Themes of True Quality 2022

By Kennedy Gennari on February 25, 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

By Nick Tippmann on February 24, 2022

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?

By Nick Tippmann on February 23, 2022

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

By Wade Schroeder on February 18, 2022

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

By Nick Tippmann on February 17, 2022

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

By Nick Tippmann on February 16, 2022

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?

By Niki Price on February 13, 2022

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

By Kennedy Gennari on February 11, 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

By Sara Adams on February 6, 2022

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

By Wade Schroeder on February 4, 2022

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.

By Nick Tippmann on February 3, 2022

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

By Nick Tippmann on February 3, 2022

New functionality empowers users to build bills of materials (BOMs), manage product families, and st...

How to Select a Contract Manufacturer

By Nick Tippmann on February 2, 2022

What is the best way for medical device professionals, early-stage, and established companies to sel...

What Should Really Trigger a CAPA?

By Sara Adams on January 30, 2022

Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers...

10 Reasons to Attend True Quality 2022

By Kennedy Gennari on January 28, 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

By Nick Tippmann on January 26, 2022

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

By Kennedy Gennari on January 25, 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

By Nick Tippmann on January 25, 2022

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

By Laura Court on January 21, 2022

When it comes to complexity, medical devices run the gamut.

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

By Nick Tippmann on January 19, 2022

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

By David DeRam on January 19, 2022

Greenlight Guru Acquires CanvasGT to Dramatically Enhance Iterative Design Planning for Medical Devi...

Greenlight Guru Acquires Visual Medical Design Collaboration Solution CanvasGT

By Nick Tippmann on January 19, 2022

New acquisition will allow the medical device industry’s leading software platform to provide extend...

3 Medical Device Security Challenges (and Solutions)

By Tom Rish on January 16, 2022

Technological innovations in and around the medical device industry have made it possible for compan...

How Do FDA Medical Device Recalls Work?

By Taylor Brown on January 14, 2022

For medical device companies, few things are as valuable as the public’s trust.

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

By Nick Tippmann on January 12, 2022

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

By Taylor Brown on January 9, 2022

The goal of any medical device is to improve the lives of its users.

ISO 11137: An Introduction to Gamma Sterilization Validation

By Etienne Nichols on January 7, 2022

For many medical device companies, sterilization is one of the final hurdles they have to clear befo...

Understanding the UDI System for Medical Devices

By Nick Tippmann on January 5, 2022

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

By Etienne Nichols on December 30, 2021

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)

By Nick Tippmann on December 26, 2021

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

By Tom Rish on December 21, 2021

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

By Nick Tippmann on December 19, 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

By Etienne Nichols on December 17, 2021

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

By Nick Tippmann on December 16, 2021

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

By Nick Tippmann on December 16, 2021

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

By Wade Schroeder on December 14, 2021

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

By Jesseca Lyons on December 12, 2021

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

By Wade Schroeder on December 10, 2021

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?

By Laura Court on December 9, 2021

When medical device manufacturers hope to bring a new and perhaps revolutionary medical device to ma...

How Augmented Reality (AR) is Revolutionizing Healthcare

By Nick Tippmann on December 8, 2021

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

By Sara Adams on December 7, 2021

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

By Etienne Nichols on December 5, 2021

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

By Laura Court on December 3, 2021

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

By Nick Tippmann on December 1, 2021

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

By Taylor Brown on November 30, 2021

In 2017, the European Commission (EC) released two new regulations, one specific to medical devices ...

Ultimate List of ISO Standards for Medical Devices

By Tom Rish on November 28, 2021

The International Standardization Organization (ISO) is an independent, non-governmental organizatio...

Why Usability Matters

By Nick Tippmann on November 24, 2021

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

By Taylor Brown on November 23, 2021

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

By Jesseca Lyons on November 21, 2021

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

By Wade Schroeder on November 19, 2021

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

By Nick Tippmann on November 17, 2021

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

By Nick Tippmann on November 17, 2021

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

By Laura Court on November 16, 2021

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

By Taylor Brown on November 14, 2021

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

By Etienne Nichols on November 12, 2021

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

By Taylor Brown on November 11, 2021

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?

By Nick Tippmann on November 10, 2021

Medical device companies must comply with a list of strict requirements throughout the duration of t...

What are the SaMD Requirements from FDA?

By Wade Schroeder on November 10, 2021

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

By Nick Tippmann on November 9, 2021

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

By Tom Rish on November 8, 2021

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?

By Ryan Behringer on November 4, 2021

Failure mode effects analysis (FMEA) is one of the best-known risk management tools within engineeri...

Setting the Record Straight on Usability & Human Factors

By Nick Tippmann on November 3, 2021

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?

By Tom Rish on November 2, 2021

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

By Leo Eisner on October 31, 2021

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

7 Project Management Tips

By Jon Speer on October 28, 2021

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

By Nick Tippmann on October 27, 2021

How should you approach project management for medical device product development ? Stop managing yo...

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

By Laura Court on October 26, 2021

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

By Etienne Nichols on October 24, 2021

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?

By Tom Rish on October 22, 2021

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

By Wade Schroeder on October 21, 2021

Clinical testing of medical devices is a critically important step in ensuring the safety and effica...

Assessing the Global Regulatory Landscape

By Nick Tippmann on October 20, 2021

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

By Formlabs on October 17, 2021

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

By EMERGO by UL on October 15, 2021

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

By Wade Schroeder on October 14, 2021

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

By Nick Tippmann on October 13, 2021

In this episode of the Global Medical Device Podcast, Jon Speer talks to Herschel “Buzz” Peddicord, ...

European Authorized Representative for Medical Device Companies

By EMERGO by UL on October 12, 2021

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

By Etienne Nichols on October 10, 2021

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?

By Tom Rish on October 8, 2021

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)?

By Sara Adams on October 7, 2021

Quality management is an essential part of manufacturing any product, regardless of size, complexity...

When to Throw the Least Burdensome Flag on FDA

By Nick Tippmann on October 6, 2021

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?

By Sara Adams on October 5, 2021

When it comes to medical devices, compliance isn’t based on the honor system.

Creating a Quality Manual That Complies with ISO 13485

By Taylor Brown on October 3, 2021

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

By Nick Tippmann on September 28, 2021

“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

By Jon Speer on September 26, 2021

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

By Nick Tippmann on September 24, 2021

“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

By Nick Tippmann on September 23, 2021

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

By Nick Tippmann on September 22, 2021

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?

By Ryan Behringer on September 21, 2021

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

By Tom Rish on September 19, 2021

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

By Jon Speer on September 17, 2021

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

By Nick Tippmann on September 16, 2021

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

By Nick Tippmann on September 15, 2021

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the...

What is the FDA Medical Device Registration Process?

By Laura Court on September 14, 2021

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)

By Jon Speer on September 13, 2021

So you need to make a change to your medical device, what now?

Top 3 Reasons for FDA 483 Observations in 2020

By Etienne Nichols on September 12, 2021

The US Food and Drug Administration (FDA) has released the quality system inspection data for citati...

How to Use the MDSAP Companion Document

By Taylor Brown on September 10, 2021

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

By Nick Tippmann on September 8, 2021

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

By Wade Schroeder on September 6, 2021

Software as a Medical Device (SaMD) is a rapidly growing subset of the medical device industry, and ...

Goodbye EN 1041. Hello ISO 20417:2021.

By Ryan Behringer on September 6, 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

By Jon Speer on September 3, 2021

In the medical device industry, innovation is a complicated subject.

Meet a Guru: Maryann Mitchell

By Nick Tippmann on September 1, 2021

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)

By Sara Adams on August 29, 2021

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality m...

Why Storytelling Matters for Medical Device Companies

By Nick Tippmann on August 25, 2021

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

By Nick Tippmann on August 24, 2021

David DeRam, CEO of Greenlight Guru, credits mindset techniques such as autohypnosis for both rowing...

5 Postmarket Surveillance System Musts for Every EU Manufacturer

By Sara Adams on August 22, 2021

Designing, developing, and getting your medical device approved and onto the market is a huge accomp...

A Breakthrough Device that Aims to Prevent Osteoporosis

By Nick Tippmann on August 18, 2021

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

By Taylor Brown on August 16, 2021

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

By Nick Tippmann on August 13, 2021

Understanding FDA's New Intended Use Rule and its Implications

By Nick Tippmann on August 11, 2021

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

By Wade Schroeder on August 8, 2021

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

By Nick Tippmann on August 6, 2021

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

By Etienne Nichols on August 1, 2021

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

By Nick Tippmann on July 30, 2021

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...

eQMS in Academia: Practical Learning for Biomedical Engineering Students

By Nick Tippmann on July 28, 2021

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

By Tom Rish on July 26, 2021

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?

By Laura Court on July 23, 2021

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

By Nick Tippmann on July 19, 2021

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

By Wade Schroeder on July 18, 2021

If you’re developing a medical device that uses software, or developing SaMD (Software as a Medical ...

Understanding the FDA Medical Device Classification System

By Ryan Behringer on July 16, 2021

The world of medical devices is one of the most varied and complex industries around today. Innovati...

Meet a Guru: Ryan Behringer

By Nick Tippmann on July 14, 2021

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device com...

Navigating the MedTech Cybersecurity Ecosystem

By Nick Tippmann on July 12, 2021

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

By Wade Schroeder on July 11, 2021

As more and more medical devices utilizing network connection technology are developed, cybersecurit...

Choosing and Managing Your Medical Device Suppliers

By Sara Adams on July 9, 2021

Managing your medical device suppliers is a core responsibility of manufacturers.

Managing Clinical Data Activities

By Nick Tippmann on July 7, 2021

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

By Etienne Nichols on July 4, 2021

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

By Nick Tippmann on July 2, 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

By Nick Tippmann on June 30, 2021

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?

By Laura Court on June 28, 2021

Medical device labeling is a core requirement for getting your device onto the market.

Understanding Intended Use from ISO TR 24971:2020

By Jon Speer on June 25, 2021

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

By Nick Tippmann on June 23, 2021

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

By Nick Tippmann on June 22, 2021

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

By Nick Tippmann on June 21, 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

By Etienne Nichols on June 18, 2021

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

By Nick Tippmann on June 16, 2021

Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device ...

Greenlight Guru Announces Medical Device HQ Partnership

By Nick Tippmann on June 16, 2021

New partnership with training experts will allow the medical device industry’s leading software plat...

Greenlight Guru Receives Strategic Growth Investment from JMI Equity

By Nick Tippmann on June 15, 2021

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

By Nick Tippmann on June 14, 2021

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

By Wade Schroeder on June 11, 2021

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

By Jon Speer on June 11, 2021

How Mindset Training Can Help Your Team Operate at Peak Performance

By Nick Tippmann on June 9, 2021

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

By Nick Tippmann on June 7, 2021

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

By Taylor Brown on June 6, 2021

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

By Nick Tippmann on June 3, 2021

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

By Nick Tippmann on June 2, 2021

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

By Tom Rish on May 31, 2021

Clinical investigations play an important role in your journey of bringing a medical device to marke...

Building your Brand as a Medical Device Professional

By Nick Tippmann on May 31, 2021

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?

By Jon Speer on May 28, 2021

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

By Nick Tippmann on May 27, 2021

Leading medical device QMS provider establishes Regulatory Advisory Board comprised of global regula...

Understanding the Value of a Medical Device Guru

By Nick Tippmann on May 26, 2021

Have you ever wondered, what does a medical device guru actually do? What role do they play within G...

Meet a Guru: Etienne Nichols

By Nick Tippmann on May 24, 2021

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

By Tom Rish on May 23, 2021

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?

By Laura Court on May 21, 2021

Could your medical device qualify for an investigational device exemption (IDE)?

Meet a Guru: Laura Court

By Nick Tippmann on May 19, 2021

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

By Nick Tippmann on May 17, 2021

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

By Jon Speer on May 16, 2021

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

By Sara Adams on May 14, 2021

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

By PA Consulting on May 13, 2021

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?)

By Nick Tippmann on May 12, 2021

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles...

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

By Nick Tippmann on May 11, 2021

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

By Etienne Nichols on May 9, 2021

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

By Wade Schroeder on May 7, 2021

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?

By Nick Tippmann on May 6, 2021

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

By PA Consulting on May 6, 2021

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

By Nick Tippmann on May 4, 2021

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...

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