Medical Device Quality, Regulatory and Product Development Blog

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...

Top 40+ Medical Device Conferences To Attend in 2020

By Nick Tippmann on June 8, 2021

Simply attending the right medical device conference can be a game-changer for those who work in the...

Examining the HHS Proposal for Premarket Notification Exemptions

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...

Managing Business Risk as a Medical Device Company

By Nick Tippmann on May 3, 2021

It's easy to get so wrapped up in the risk management of your medical device that you forget about m...

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

By Wade Schroeder on May 2, 2021

Medical device usability testing and validation are critical tasks leading up to a medical device’s ...

Waterfall vs. Agile: Battle of the Product Development Methodologies

By Nick Tippmann on April 28, 2021

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?

For the Love of Internal Auditing

By Nick Tippmann on April 26, 2021

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me...

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

By Jesseca Lyons on April 25, 2021

The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical ...

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

By Nick Tippmann on April 21, 2021

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a ...

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

By PA Consulting on April 20, 2021

Healthcare provider market demands are such that medical device companies often find themselves in s...

Knowing vs. Doing as Medical Device Professionals

By Nick Tippmann on April 19, 2021

For medical device professionals, there are the “knowers” and the “doers.”

How to Structure your Medical Device Technical File

By Jon Speer on April 18, 2021

The medical device technical file is a must-have document for devices to be sold in the EU marketpla...

Greenlight Guru Named Premier QMS Software for NIH RADx Initiative

By Nick Tippmann on April 15, 2021

MDQMS leader to support national COVID-19 diagnostics program through purpose-built solutions.

Pivoting Operations to Meet PPE Demand during Pandemic

By Nick Tippmann on April 14, 2021

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, ar...

Pros & Cons of Being a Physician turned MedTech Inventor

By Nick Tippmann on April 13, 2021

Do you fear needles and the associated pain? No one understands this fear more than physicians who s...

What is a Quality Agreement for Medical Devices?

By Taylor Brown on April 11, 2021

There’s a good chance you’re not manufacturing your own medical device—contract medical device manuf...

3 Systems of Risk for Medical Devices from FDA

By Nick Tippmann on April 7, 2021

Why does FDA have three systems in place to address and handle risk for medical devices? Each system...

Quality Management for IVD Devices vs Medical Devices

By Nick Tippmann on April 5, 2021

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD...

Am I Complying with FDA Medical Device Labeling Requirements?

By Jesseca Lyons on April 4, 2021

Medical device labeling requirements are a key part of getting your device to market.

Understanding the Investigational Device Exemption (IDE) Process

By Nick Tippmann on March 31, 2021

Does your medical device qualify for an investigational device exemption (IDE)? What does this proce...

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

By Nick Tippmann on March 29, 2021

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself?...

How to Use the FDA ESG (Electronic Submissions Gateway)

By Tom Rish on March 28, 2021

The most competitive medical device companies embrace technology as a tool to make systems and proce...

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

By Nick Tippmann on March 24, 2021

Why is design, manufacturing, quality, and culture so important in the medical device industry?

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

By Nick Tippmann on March 21, 2021

What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices f...

3 Valuable Outcomes of a Culture of Quality

By Jon Speer on March 21, 2021

Do you consider your medical device company to have a culture of quality?

Meet a Guru: Sara Adams

By Nick Tippmann on March 18, 2021

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical d...

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

By Nick Tippmann on March 16, 2021

The IVD market reaches into all corners of the world, and for many device companies, this niche prod...

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

By Nick Tippmann on March 15, 2021

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that h...

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

By Etienne Nichols on March 14, 2021

You’ve probably heard a traceability matrix is something you need as part of your medical device QMS...

Building a Startup in the MedTech Industry

By Nick Tippmann on March 10, 2021

What does it take to build a successful MedTech startup? It’s a multi-million dollar question and th...

Meet a Guru: Karen Schuyler

By Nick Tippmann on March 8, 2021

What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with a ton...

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

By Nick Tippmann on March 8, 2021

Greenlight Guru Academy will educate and train medical device professionals on everything they need ...

How to Demonstrate Substantial Equivalence in 5 Easy Steps

By Tom Rish on March 7, 2021

If you’re taking the 510(k) route to market for your medical device, demonstrating substantial equiv...

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

By Nick Tippmann on March 3, 2021

Imagine using medical illustrations, animations, and other types of artwork to tell the story of a m...

Everything you Need to Know about SaMD from an FDA Perspective

By Nick Tippmann on March 1, 2021

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are i...

How to Use Voluntary Consensus Standards to your Strategic Advantage

By Taylor Brown on February 28, 2021

If we were to say that it’s okay if you don’t follow all relevant standards when you develop your me...

Preparing for Remote and On-Site Inspections and Audits

By Nick Tippmann on February 24, 2021

How can medical device companies be better prepared for remote and on-site inspections and audits? P...

How does EU MDR impact your Quality Management System?

By Nick Tippmann on February 22, 2021

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challe...

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

By Wade Schroeder on February 21, 2021

If your medical device falls under premarket submission criteria, there are three types of 510(k) th...

Virtual Auditing in a Post-COVID World of Digital Compliance

By Nick Tippmann on February 17, 2021

What do auditing and compliance protocols look like during a pandemic? Medical device companies cont...

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

By Jon Speer on February 16, 2021

How valuable would it be to have a visual representation of your entire QMS and all of its functioni...

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

By Nick Tippmann on February 15, 2021

While the current health crisis has served as a catalyst for innovation for medical device companies...

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

By Taylor Brown on February 14, 2021

Your internal quality audits should be much more than a “checkbox” requirement on your compliance to...

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

By Nick Tippmann on February 10, 2021

Keeping a constant pulse on current medical device industry standards for risk management, like ISO ...

How to Create a Quality Management Plan

By Sara Adams on February 9, 2021

Technically speaking, you can launch a product without a quality management plan—but most of your go...

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

By Nick Tippmann on February 8, 2021

Leading MDQMS provider combines global regulatory leadership with original research data to provide ...

Ultimate Guide to Training Management for Medical Device Companies

By Taylor Brown on February 7, 2021

Prioritizing Medical Device Reimbursement During Product Development

By Nick Tippmann on February 3, 2021

Medical device reimbursement is a key consideration that must be well researched, understood, and ma...

Understanding ISO 13485 Training and Competency Requirements

By Tom Rish on February 2, 2021

Are the employees in your medical device company meeting the training and competency requirements of...

5 Key Principles of Total Quality Management

By Taylor Brown on January 31, 2021

It's easy to think of quality as a niche responsibility, requiring only the involvement of those wor...

5 Actionable Lessons Learned from the RADx Initiative by NIH

By Nick Tippmann on January 27, 2021

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Hea...

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

By Jon Speer on January 26, 2021

Establishing a more efficient and effective quality management system (QMS) has been a recurring que...

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

By Jon Speer on January 25, 2021

Are you gearing up to submit a 510(k)? If so, you need to have a thorough understanding of what “sub...

Definitive Guide to Change Management for Medical Devices

By Jon Speer on January 22, 2021

In an industry that is ever-evolving, change is inevitable.

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 Intelligent Document Management powered by Halo℠

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?

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...

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