Medical Device Quality, Regulatory and Product Development Blog

What are the Strategic Priorities for CDRH in 2021?

By Nick Tippmann on January 20, 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)

By Sara Adams on January 19, 2021

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 Halo℠ for Change Management

By Nick Tippmann on January 18, 2021

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

By Nick Tippmann on January 18, 2021

New predictive recommendation engine transforms the way medical device companies are able to discove...

Understanding and Handling Different Types of Feedback

By Nick Tippmann on January 14, 2021

What’s the relationship between product feedback, complaints, and adverse events?

How to Use the De Novo Pathway for your Medical Device

By Tom Rish on January 12, 2021

Is the De Novo regulatory pathway a viable option to get your medical device to market?

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

By Jon Speer on January 10, 2021

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

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

By Nick Tippmann on January 6, 2021

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

By Nick Tippmann on January 5, 2021

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

By Taylor Brown on January 4, 2021

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

By Nick Tippmann on December 23, 2020

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

By Nick Tippmann on December 20, 2020

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

By Nick Tippmann on December 16, 2020

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

By Jon Speer on December 13, 2020

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?

By Nick Tippmann on December 9, 2020

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

By Nick Tippmann on December 8, 2020

Findings of a 2021 industry benchmark survey reveal internal divides within organizations are making...

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

By Nick Tippmann on December 2, 2020

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)

By Tom Rish on December 1, 2020

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?

By Nick Tippmann on November 25, 2020

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

By Jon Speer on November 24, 2020

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

By Taylor Brown on November 23, 2020

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

By Nick Tippmann on November 18, 2020

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)

By Nick Tippmann on November 17, 2020

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

By Nick Tippmann on November 16, 2020

When you talk, we listen.

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

By Nick Tippmann on November 16, 2020

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

By Nick Tippmann on November 11, 2020

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly uti...

Developing Pediatric Medical Devices: An Innovative Approach

By Erica Loring on November 10, 2020

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

By Nick Tippmann on November 9, 2020

Leading MDQMS provider powers the conversation around the impacts of COVID-19 and other industry top...

Medical Device Biocompatibility 101

By Erica Loring on November 8, 2020

Medical device biocompatibility can be confusing, challenging, even frustrating for device professio...

Why Biocompatibility Should be Addressed by Every Medical Device Company

By Nick Tippmann on November 4, 2020

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

By Tom Rish on November 1, 2020

Human factors are a key part of medical device development and the sooner they’re addressed in the d...

Meet a Guru: Erica Loring

By Nick Tippmann on October 27, 2020

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

By Erica Loring on October 25, 2020

It was nothing more than a checklist that saved $175 million and 1,500 lives.

Free Complaint Template for Medical Devices

By Jon Speer on October 21, 2020

One of the major post-market responsibilities of medical device companies is handling customer compl...

Free Template: Nonconformance Process for your Medical Device

By Jon Speer on October 20, 2020

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

By Nick Tippmann on October 19, 2020

New capability automates the quality event process through customized templates that increase effici...

A Free CAPA Template for the Medical Device Industry

By Jon Speer on October 18, 2020

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)

By QRA Corp on October 11, 2020

With the rapidly accelerating pace of innovation in the medical device arena, the procedures and pra...

How to Write a Nonconformance Report

By Barret Mueller on October 4, 2020

Nonconformance is a word no quality manager wants to hear.

What is a Multiple Function Device?

By Nick Tippmann on September 30, 2020

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

By Jon Speer on September 27, 2020

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

By Nick Tippmann on September 21, 2020

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

By Nick Tippmann on September 20, 2020

Most people are visual learners. In fact, it has been reported that visuals can improve learning by ...

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

By Jon Speer on September 13, 2020

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

By Nick Tippmann on September 10, 2020

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

By Jon Speer on September 6, 2020

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

By Nick Tippmann on September 2, 2020

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

By Jon Speer on August 30, 2020

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

By Nick Tippmann on August 26, 2020

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

Document Control for Medical Device Companies: The Ultimate Guide

By Jon Speer on August 23, 2020

According to the original data findings of our 2020 State of Medical Device Product Development and ...

Meet a Guru: Wade Schroeder

By Nick Tippmann on August 19, 2020

What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge⁠—a team of m...

Unannounced Audits: A Survival Guide for Quality Managers

By Jon Speer on August 16, 2020

We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expecta...

What are the Audit Etiquette Rules I Should be Following?

By Nick Tippmann on August 12, 2020

Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself acco...

5 Tips for Medical Device Registration across Global Markets

By Jon Speer on August 9, 2020

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...

Meet a Guru: Tom Rish

By Nick Tippmann on August 5, 2020

What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge.

How Do I Determine if my Product is a Medical Device?

By Jon Speer on August 2, 2020

Let’s say you’re in the medical industry but not yet in the medical device industry. You’re working ...

Addressing Clinical Trial Challenges & Concerns during COVID-19

By Nick Tippmann on July 29, 2020

The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst...

What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?

By The RND Group on July 26, 2020

The FDA has released a discussion guideline and request for feedback regarding changes in the certif...

Protecting the Intellectual Property of your Medical Device Technology

By Nick Tippmann on July 22, 2020

Should you have patent protection for your medical device technology? Should you keep your secret sa...

Top 100 Medical Device Acronyms & Terminology You Need to Know

By Jon Speer on July 19, 2020

In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...

Meet a Guru: Jesseca Lyons

By Nick Tippmann on July 15, 2020

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with...

How to Escape the Lure of Legacy Quality Management Systems

By Jon Speer on July 12, 2020

Many device professionals in small to medium-sized businesses (SMB) still use legacy systems to supp...

How to Build a QMS for a Medical Device

By Nick Tippmann on July 8, 2020

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...

Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records

By Jon Speer on July 5, 2020

Some companies in the medical device industry show resistance to digital technology, preferring to u...

Meet a Guru: Taylor Brown

By Nick Tippmann on July 1, 2020

What makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over e...

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

By Jon Speer on June 28, 2020

What is the expected process you should follow for your medical device design planning and controls?

What is Regulatory Due Diligence for Medical Devices?

By Nick Tippmann on June 24, 2020

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory s...

How to Validate Cloud-based Software Tools

By The RND Group on June 21, 2020

Do you remember what computing tools you were using in 2002? I would guess, if you were old enough t...

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

By Nick Tippmann on June 17, 2020

Are you discouraged by all of the negative news and sad stories about COVID-19? Let's shift the focu...

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

By Jesseca Lyons on June 12, 2020

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

Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS

By Nick Tippmann on June 11, 2020

As medical device companies around the globe are continuing to operate among the implications of COV...

How Being Strategic During A Career Transition Can Yield The Best Opportunities

By Nick Tippmann on June 10, 2020

There is a spectrum of feelings someone may experience in the midst of a career transition. For some...

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

By Nick Tippmann on June 3, 2020

Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

By Jesseca Lyons on May 29, 2020

The medical device industry has a lot of acronyms.

How to Construct an Effective Regulatory Strategy

By Nick Tippmann on May 27, 2020

What is a regulatory strategy? What are the components involved?

22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles

By Jon Speer on May 24, 2020

The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device qua...

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

By Nick Tippmann on May 20, 2020

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end u...

EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?

By Jon Speer on May 17, 2020

On Saturday, March 28, health care workers in Los Angeles County discovered that the federal governm...

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

By Nick Tippmann on May 13, 2020

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medi...

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

By Nick Tippmann on May 6, 2020

What does the 510(k) process involve? How should medical device companies know if this is the right ...

EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic

By Jon Speer on May 3, 2020

The EU Medical Device Regulation (MDR) has been a source of stress for medical device companies arou...

How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends

By Jon Speer on May 3, 2020

Medical device companies are among the most important players in the world’s response to COVID-19.

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

By Nick Tippmann on April 29, 2020

Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for fr...

Greenlight Guru and EMERGO by UL Announce Strategic Alliance to Simplify and Automate Global Market Access for Medical Device Companies

By Nick Tippmann on April 27, 2020

Bundled offerings equip medical device manufacturers to better navigate regulatory pathways, bring d...

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

By Nick Tippmann on April 22, 2020

What impact will the EU MDR changes have on the medical device ecosystem?

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

By Tommy Cooper on April 19, 2020

A common dilemma for early stage medical device companies is their lack of expertise in medical devi...

How to Approach Verification and Validation for Cloud Software

By Nick Tippmann on April 15, 2020

Why is verification and validation (V&V) confusing and challenging for many medical device professio...

How Software Architecture Enables Faster Release of New Clinical Tests to the Market

By The RND Group on April 12, 2020

The ultimate goal of developing a medical device is to receive FDA approval and to be able to releas...

What are the Changes to ISO 14971:2019 & TR 24971?

By Jon Speer on April 12, 2020

Proper risk management is a key process throughout the entire life cycle of a medical device. This i...

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

By Nick Tippmann on April 10, 2020

During the COVID-19 crisis, medical device companies are improving and saving the lives of healthcar...

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

By Nick Tippmann on April 8, 2020

What qualifies and what does not for Emergency Use Authorization (EUA)? What is the impact of this r...

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

By Jon Speer on April 5, 2020

COVID-19 has thrown the medical community into a frenzy. Hospitals are struggling as the disease spr...

10 Ways A Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead

By Nick Tippmann on April 4, 2020

During unprecedented times, medical device companies are finding themselves facing unusual challenge...

How to Integrate Usability into your Medical Device

By Nick Tippmann on April 1, 2020

Medical device usability is a critical, yet confusing component of medical device design, developmen...

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

By Jon Speer on March 29, 2020

Throughout 2020, the medical device industry will see significant changes take flight. Among the big...

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

By Nick Tippmann on March 26, 2020

In this modern digital world, did you know that most medical devices are not connected to the Intern...

Medical Device Companies - Top 100 in 2020 (Free Chart)

By Nick Tippmann on March 24, 2020

Have you ever wondered about the biggest medical device companies in the world? Maybe you're looking...

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

By Jon Speer on March 22, 2020

With the deadline for compliance with the EU MDR just around the corner, big changes are being made ...

How to Leverage IEC 62304 to improve SaMD Development Processes

By Nick Tippmann on March 18, 2020

How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) dev...

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

By Nick Tippmann on March 12, 2020

The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) ...

Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities

By Nick Tippmann on March 9, 2020

Medical device quality management system (MDQMS) aligns with latest version of globally recognized r...

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

By Jon Speer on March 1, 2020

How a company chooses to establish and maintain their quality system has everything to do with their...

How to Choose the Right FDA Regulatory Pathway for your Device

By Nick Tippmann on February 26, 2020

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

By Jon Speer on February 25, 2020

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

By Jon Speer on February 21, 2020

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

By Nick Tippmann on February 19, 2020

Regulatory is a big deal for medical device companies. Whether it’s a startup or established busines...

7 FDA Pathways to Bring Your Medical Device to Market

By Tom Rish on February 16, 2020

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...