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How to Structure your Medical Device Technical File - Featured Image

How to Structure your Medical Device Technical File

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

Greenlight Guru Named Premier QMS Software for NIH RADx Initiative

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

Pivoting Operations to Meet PPE Demand during Pandemic

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

Pros & Cons of Being a Physician turned MedTech Inventor

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

What is a Quality Agreement for Medical Devices?

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

3 Systems of Risk for Medical Devices from FDA

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

Quality Management for IVD Devices vs Medical Devices

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

Am I Complying with FDA Medical Device Labeling Requirements?

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

Understanding the Investigational Device Exemption (IDE) Process

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

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

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

How to Use the FDA ESG (Electronic Submissions Gateway)

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

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

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

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

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

3 Valuable Outcomes of a Culture of Quality

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

Meet a Guru: Sara Adams

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

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

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

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

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

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

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

Building a Startup in the MedTech Industry

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

Meet a Guru: Karen Schuyler

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

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

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

How to Demonstrate Substantial Equivalence in 5 Easy Steps

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

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

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

Everything you Need to Know about SaMD from an FDA Perspective

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

How to Use Voluntary Consensus Standards to your Strategic Advantage

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

Preparing for Remote and On-Site Inspections and Audits

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

How does EU MDR impact your Quality Management System?

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

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

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

Virtual Auditing in a Post-COVID World of Digital Compliance

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

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

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

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

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

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

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

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

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

How to Create a Quality Management Plan

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

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

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

Ultimate Guide to Training Management for Medical Device Companies

Prioritizing Medical Device Reimbursement During Product Development - Featured Image

Prioritizing Medical Device Reimbursement During Product Development

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

Understanding ISO 13485 Training and Competency Requirements

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

5 Key Principles of Total Quality Management

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

5 Actionable Lessons Learned from the RADx Initiative by NIH

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

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

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

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

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

Definitive Guide to Change Management for Medical Devices

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

What are the Strategic Priorities for CDRH in 2021?

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

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

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

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

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

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

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

Understanding and Handling Different Types of Feedback

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

How to Use the De Novo Pathway for your Medical Device

Is the De Novo regulatory pathway a viable option to get your medical device to market?
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

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

So you need to make a change to your medical device, what now?
Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape - Featured Image

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

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

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

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

Understanding Change Management and Change Control in the Medical Device Industry

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

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

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

Most Popular Medical Device Content in 2020 from Greenlight Guru

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

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

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

6 Benefits of the Best 21 CFR Part 11 Compliant Software

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

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

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

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

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

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

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

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

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

What Goes into Designing Devices for Military and Emergency Applications?

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

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

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

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

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

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

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

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

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

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

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

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

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

Positive and Negative Impacts of EUA on the Medical Device Industry

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

Developing Pediatric Medical Devices: An Innovative Approach

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

Greenlight Guru Announces The 2021 State of Medical Device Virtual Summit

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

Medical Device Biocompatibility 101

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

Why Biocompatibility Should be Addressed by Every Medical Device Company

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

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

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

Meet a Guru: Erica Loring

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

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

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

Free Complaint Template for Medical Devices

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

Free Template: Nonconformance Process for your Medical Device

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

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

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

A Free CAPA Template for the Medical Device Industry

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

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

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

How to Write a Nonconformance Report

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

What is a Multiple Function Device?

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

3 Reasons Why Closed-Loop Traceability is a QMS Must

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

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

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

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

Most people are visual learners. In fact, it has been reported that visuals can improve learning by ...
CAPA Process - Step-by-Step Instructions [Infographic] - Featured Image

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

CAPA is an area that we talk about often, mainly because it’s still such a big issue for medical dev...
Challenges related to Home Use Devices - Featured Image

Challenges related to Home Use Devices

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

Quality Assurance vs. Quality Control in the Medical Device Industry

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

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

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

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

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

How Jon Speer Met His Most Frequent Guest: Mike Drues

Reminiscing about past and present lessons learned from listening to conversations with this show’s ...
Document Control for Medical Device Companies: The Ultimate Guide - Featured Image

Document Control for Medical Device Companies: The Ultimate Guide

According to the original data findings of our 2020 State of Medical Device Product Development and ...
Meet a Guru: Wade Schroeder - Featured Image

Meet a Guru: Wade Schroeder

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 - Featured Image

Unannounced Audits: A Survival Guide for Quality Managers

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? - Featured Image

What are the Audit Etiquette Rules I Should be Following?

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 - Featured Image

5 Tips for Medical Device Registration across Global Markets

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...
Meet a Guru: Tom Rish - Featured Image

Meet a Guru: Tom Rish

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? - Featured Image

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

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 - Featured Image

Addressing Clinical Trial Challenges & Concerns during COVID-19

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? - Featured Image

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

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 - Featured Image

Protecting the Intellectual Property of your Medical Device Technology

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 - Featured Image

Top 100 Medical Device Acronyms & Terminology You Need to Know

In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...
Meet a Guru: Jesseca Lyons - Featured Image

Meet a Guru: Jesseca Lyons

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 - Featured Image

How to Escape the Lure of Legacy Quality Management Systems

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 - Featured Image

How to Build a QMS for a Medical Device

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 - Featured Image

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

Some companies in the medical device industry show resistance to digital technology, preferring to u...
Meet a Guru: Taylor Brown - Featured Image

Meet a Guru: Taylor Brown

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 - Featured Image

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

What is the expected process you should follow for your medical device design planning and controls?
What is Regulatory Due Diligence for Medical Devices? - Featured Image

What is Regulatory Due Diligence for Medical Devices?

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 - Featured Image

How to Validate Cloud-based Software Tools

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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

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? - Featured Image

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

The medical device industry has a lot of acronyms. 
How to Construct an Effective Regulatory Strategy - Featured Image

How to Construct an Effective Regulatory Strategy

What is a regulatory strategy? What are the components involved?
22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles - Featured Image

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

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) - Featured Image

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

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? - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic

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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

Bundled offerings equip medical device manufacturers to better navigate regulatory pathways, bring d...
[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem - Featured Image

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

What impact will the EU MDR changes have on the medical device ecosystem?
Documentation Priority for Early Stage Medtechs — Part 1: User Specification - Featured Image

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

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 - Featured Image

How to Approach Verification and Validation for Cloud Software

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 - Featured Image

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

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? - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

During unprecedented times, medical device companies are finding themselves facing unusual challenge...
How to Integrate Usability into your Medical Device - Featured Image

How to Integrate Usability into your Medical Device

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 - Featured Image

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

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) - Featured Image

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

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) - Featured Image

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

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 - Featured Image

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

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 - Featured Image

How to Leverage IEC 62304 to improve SaMD Development Processes

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? - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

How to Choose the Right FDA Regulatory Pathway for your Device

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 - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

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

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

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 - Featured Image

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

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 - Featured Image

7 FDA Pathways to Bring Your Medical Device to Market

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...
[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS - Featured Image

[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS

How can I justify the costs of implementing medical device specific quality management software at m...
[VIDEO] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase) - Featured Image

[VIDEO] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase)

How can I track the effectiveness of my QMS after my medical device goes to market? We'll cover the ...
[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase) - Featured Image

[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase)

Is my QMS ready for the product launch of my medical device? Which quality processes should I implem...
[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase) - Featured Image

[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase)

How can I prepare my QMS to approve my medical device for manufacturing from a design transfer? Lear...
[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase) - Featured Image

[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase)

Which QMS processes should be established during product development? We'll explain how design contr...
[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase) - Featured Image

[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase)

How do I know which regulations apply to my medical device? What should I include in my quality plan...
[VIDEO] How to build a medical device QMS using the best people, processes & technology (S.M.A.R.T Methodology) - Featured Image

[VIDEO] How to build a medical device QMS using the best people, processes & technology (S.M.A.R.T Methodology)

Which quality processes should I establish first when implementing a medical device quality manageme...
4 Parts to Interviewing Candidates for Medical Device Roles - Featured Image

4 Parts to Interviewing Candidates for Medical Device Roles

Are you looking to hire medical device professionals? Or, are you a professional seeking new job opp...
Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets) - Featured Image

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

As leaders of medical device companies, our goal is always to create devices that are safe and effec...
5 Tips for Hiring Medical Device Advisors - Featured Image

5 Tips for Hiring Medical Device Advisors

Everybody seeks advice and opinions from others from time to time, even those in the medical device ...
2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020 - Featured Image

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

What top priorities can medical device professionals and patients expect in 2020 from the Center for...
4 Major Reasons to Use Document Version Control Software for your Medical Device - Featured Image

4 Major Reasons to Use Document Version Control Software for your Medical Device

With the incredible volume of documentation required by the FDA and ISO, using a document control sy...
7 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

7 Tips to Comply With FDA 21 CFR Part 11

When it comes to regulatory compliance for medical device companies, there can be some confusion aro...
5 Steps for Getting your CE Marking with EU MDR Requirements - Featured Image

5 Steps for Getting your CE Marking with EU MDR Requirements

It has long been thought that the quickest path to market for medical device manufacturers is to acc...
The Art of Defining Design Inputs And Design Outputs - Featured Image

The Art of Defining Design Inputs And Design Outputs

Design inputs are the king of medical device product development. If a product that is in the market...
15 Questions to Ask QMS Software Vendors in the Medical Device Industry - Featured Image

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

As a medical device company, you are expected to deliver innovative, life-changing medical device(s)...
Medical Device Classification Guide - How To Determine Your Device Class - Featured Image

Medical Device Classification Guide - How To Determine Your Device Class

What I am about to share with you is a guide to medical device regulatory classification.
Top 10 Most Popular Greenlight Guru Posts of 2019 - Featured Image

Top 10 Most Popular Greenlight Guru Posts of 2019

Thank you for helping make 2019 another big and exciting year for Greenlight Guru!
Navigating the Twists and Turns of Change Management for Medical Devices - Featured Image

Navigating the Twists and Turns of Change Management for Medical Devices

Change is constant… Especially in the medical device industry. Medical device change management can ...
Top 40+ Medical Device Conferences To Attend in 2020 - Featured Image

Top 40+ Medical Device Conferences To Attend in 2020

Simply attending the right medical device conference can be a game-changer for those who work in the...
What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers? - Featured Image

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...
3 Pros and Cons to 3D Printing for Medical Devices - Featured Image

3 Pros and Cons to 3D Printing for Medical Devices

3D printing processes — which use digital models to create physical devices out of materials like pl...
5 Myths about QA/RA Recruiting in the Medical Device Industry - Featured Image

5 Myths about QA/RA Recruiting in the Medical Device Industry

Recruiting top, elite quality assurance and regulatory affairs (QA/RA) talent in the medical device ...
Greenlight Guru Announces Enhanced Change Management Capabilities - Featured Image

Greenlight Guru Announces Enhanced Change Management Capabilities

Medical device quality management system (MDQMS) improves traceability and efficiency associated wit...
How to Solve the Medtech Value Equation with Quality Data - Featured Image

How to Solve the Medtech Value Equation with Quality Data

Which medical technology, product, or device are you actively focused on bringing to market that wil...
FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid - Featured Image

FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid

If you’re a medical device company selling or planning to sell into the US market, you should be fam...
Why Supplier Quality Management Is So Important - Featured Image

Why Supplier Quality Management Is So Important

Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...
State of Medical Device Product Development and Quality Management Report 2020 - Featured Image

State of Medical Device Product Development and Quality Management Report 2020

Greenlight Guru, the only medical device quality management system (MD QMS) software platform, today...
FDA is Expanding its Case for Quality Program... Should Your Company Participate? - Featured Image

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...
Preparing for EU MDR - Featured Image

Preparing for EU MDR

Do you have a regulatory strategy to help your company prepare for the new European Medical Device R...
Tips for Success with IEC 60601 for Electrical Medical Devices - Featured Image

Tips for Success with IEC 60601 for Electrical Medical Devices

Does your company develop electrical medical devices? The standard IEC 60601 is different from other...
Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction - Featured Image

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

Quality Assurance and Regulatory Affairs (QA/RA) professionals need to keep their finger on the puls...
EU MDR Implementation Guide - Featured Image

EU MDR Implementation Guide

The European medical device industry will undergo significant changes as a result of the new medical...
How FDA Distinguishes Between Clearance vs. Approval vs. Granted - Featured Image

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

As a medical device professional, you are well aware of how much time and effort goes into getting y...
C2DX, Inc. Impresses auditors and Breezes through MDSAP AUDIT After Implementing Medical Device QMS (MDQMS) - Featured Image

C2DX, Inc. Impresses auditors and Breezes through MDSAP AUDIT After Implementing Medical Device QMS (MDQMS)

  Experienced medical device professionals can agree that investing in quality early on and putting ...
Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device? - Featured Image

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devi...
7 Tips to Attract Investors and Raise Funds for your Medical Device - Featured Image

7 Tips to Attract Investors and Raise Funds for your Medical Device

Is your medical device company in the midst of raising funds or planning to begin the process? There...
Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device - Featured Image

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

Surgery can be a challenging experience, not only for patients, but their clinicians and caregivers,...
5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company - Featured Image

5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company

As a medical device manufacturer, your quality management system is the heart of your operations. 
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents - Featured Image

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...
4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them) - Featured Image

4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)

Effective planning is the key to success for any business but to an even greater degree in the medic...
Leveraging Technology and Rapid Prototyping Methodologies during Product Development - Featured Image

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Do you know everything there is to know about prototyping, product iteration, and manufacturing to g...
Complete Guide to Bringing a Medical Device to Market - Featured Image

Complete Guide to Bringing a Medical Device to Market

Best Practices for Expediting Your Product Development - Featured Image

Best Practices for Expediting Your Product Development

Speed to market is one of the major challenges for medical device companies. So, how can you expedit...
Why Design Verification Matters in Medical Device Design and Development - Featured Image

Why Design Verification Matters in Medical Device Design and Development

Design verification can be a difficult stage for medical device companies to carry out effectively. ...
5 Tips from MedTech Executives on the Value of Quality - Featured Image

5 Tips from MedTech Executives on the Value of Quality

When it comes to making medical devices, quality is key.
Implementing Changes to SaMD under New EU MDR - Featured Image

Implementing Changes to SaMD under New EU MDR

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the ne...
Career Tips for QA/RA Professionals in the Medical Device Industry - Featured Image

Career Tips for QA/RA Professionals in the Medical Device Industry

Medical device quality and regulatory professionals face changes, challenges, requirements, standard...
Why the FDA Pre-Submission is an Underutilized Tool - Featured Image

Why the FDA Pre-Submission is an Underutilized Tool

“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...
Right-sizing your QMS - Featured Image

Right-sizing your QMS

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of...

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

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