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Greenlight Guru Medical Device Blog

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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featured

Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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MedTech Lifecycle Excellence

Bringing a Self-Funded Medical Device to Market

Etienne Nichols
April 25, 2024
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow... Read More
MedTech Lifecycle Excellence

Managing Risk in Clinical Investigations

Etienne Nichols
April 23, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. Read More
MedTech Lifecycle Excellence

FDA’s PMA Supplements and Amendments: When and How to Use Each

Etienne Nichols
April 19, 2024
The regulatory pathway for getting a Class III medical device to market in the US is known as Premarket Approval (PMA). Given that Class III devices pose the highest risk to... Read More
MedTech Lifecycle Excellence

Speaking the Language of IVD

Etienne Nichols
April 18, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal... Read More
MedTech Lifecycle Excellence

Is It Possible to "Buy" a QMS?

Etienne Nichols
April 12, 2024
In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry. Read More
Clinical Data Collection

Ultimate Guide to Clinical Data Management in MedTech

Chris Rush
April 12, 2024
For many MedTech companies, especially those that manufacture high-risk devices, clinical trials are a crucial part of getting medical devices to market and keeping them... Read More
MedTech Lifecycle Excellence

What is a Class III Medical Device in the US?

Etienne Nichols
April 8, 2024
In the US, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all... Read More
MedTech Lifecycle Excellence

Project Management in MedTech

Etienne Nichols
April 4, 2024
This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management... Read More
Post-Market Surveillance

Improving Study Management in MedTech with Greenlight Guru Clinical’s Custom Collaborator Roles

Páll Jóhannesson
April 4, 2024
Greenlight Guru Clinical's recent introduction of Custom Collaborator Roles provides vital support to the MedTech clinical study arena. This feature brings a targeted... Read More
MedTech Lifecycle Excellence

Greenlight Guru Shines in G2 Spring 2024 Report, Dominating in Medical QMS and EDC Categories

Tory Lopez
April 4, 2024
This recognition underlines Greenlight Guru's commitment to innovation and customer-centric service in the MedTech industry. Read More
Clinical Data Collection

Meeting Timelines and Managing Budgets - Best Practices for MedTech Clinical Investigations

Chris Rush
April 3, 2024
If there is one universal truth in MedTech clinical trials, it is that your study will take more time than you allot for it initially. Everyone, and I mean everyone,... Read More
Regulatory Submission

Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices

Etienne Nichols
April 2, 2024
The premarket approval (PMA) process is the method FDA uses to evaluate the safety and effectiveness of Class III medical devices before they can be placed on the US market. Read More
MedTech Lifecycle Excellence

How to Take Control of Training Management and Stay Compliant with ISO 13485:2016 and Part 820.25

Sara Adams
March 27, 2024
In Greenlight Guru’s 2024 State of the MedTech Industry Report, respondents cited a number of common challenges related to training management, including: Read More
MedTech Lifecycle Excellence

FDA's Voluntary Improvement Program

Etienne Nichols
March 21, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss... Read More
MedTech Lifecycle Excellence

The State of UDI Across the World

Etienne Nichols
March 7, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and... Read More
MedTech Lifecycle Excellence

Adopting AI in Quality Management: Practical Solutions for the MedTech Industry

Etienne Nichols
March 5, 2024
In MedTech, an increasing number of companies are introducing devices integrated with AI technologies. Read More
Clinical Data Collection

Outsourcing Clinical Activities in 2024: Choosing A CRO

Chris Rush
March 4, 2024
In Greenlight Guru’s 2024 State of the MedTech Industry Report, 70% of respondents told us they were going to outsource at least some of their clinical activities to a... Read More
Establishing a QMS

ALM and Design Controls: Do SaMD and SiMD Manufacturers Need Both?

Wade Schroeder
February 26, 2024
One consequence of the massive growth of software as a medical device (SaMD) and software in a medical device (SiMD) is the growing overlap between the realms of software... Read More
MedTech Lifecycle Excellence

Quality Myths & Lessons Learned Part II

Etienne Nichols
February 22, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. Read More
Establishing a QMS

How MHRA is Regulating Medical Devices in the UK after Brexit

Wade Schroeder
February 22, 2024
If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in the regulatory landscape resulting from Brexit are relevant to you. Read More
Post-Market Surveillance

Investigator Initiated Studies — 3 Common Problems and How to Fix Them

Chris Rush
February 22, 2024
An investigator initiated study (IIS) is a clinical trial of a device that is sponsored by an independent researcher, rather than the manufacturer of the device. The clinical... Read More
Establishing a QMS

5 Habits of Highly Effective MedTech Companies

Tory Lopez
February 20, 2024
At Greenlight Guru, our annual State of the MedTech Industry Report offers a comprehensive view of our industry and the opinions and outlook of more than 500 MedTech... Read More
MedTech Lifecycle Excellence

Mastering the Pitch: MedTech Innovations from Concept to Market

Etienne Nichols
February 20, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols dives into the art of pitching to medical device investors with Blythe Karow, COO at Neurogeneces. Read More
MedTech Lifecycle Excellence

How to Use the Turtle Diagram for Better Internal Audits

Jamie Bihary
February 9, 2024
An internal audit can be an overwhelming prospect, especially if you’re new to the company or internal auditing in general. Read More
MedTech Lifecycle Excellence

Greenlight Guru Announces the 2024 True Quality Roadshow

Kennedy Gennari
February 9, 2024
The free MedTech event series will make stops in four cities, including an international event in Europe. Read More
MedTech Lifecycle Excellence

Becoming a MedTech Regulatory Affairs Professional

Etienne Nichols
February 7, 2024
In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory... Read More
Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
On January 31st, 2024, FDA issued their final rule amending the Quality System Regulation (QSR) to better align with ISO 13485:2016, the international standard for quality... Read More
MedTech Lifecycle Excellence

Calculating Nonconformance Costs in the MedTech Industry

Etienne Nichols
February 2, 2024
In the MedTech industry, nonconformance costs are about more than just your company’s bottom line. Read More
MedTech Lifecycle Excellence

Introducing Risk Reviews for Efficient, Compliant Risk Management

Tory Lopez
February 2, 2024
This week at Greenlight Guru, we released several new updates to Greenlight Guru Quality, including Risk Reviews, the latest addition to our new Risk Management workspace. Read More
Product Development

Selecting a Notified Body: How to Work with Your New Device Authority

Ben Bancroft
February 1, 2024
Before you can market your product in the European Union, medical device manufacturers must undergo a conformity assessment carried out by a Notified Body (NB) in order to... Read More
MedTech Lifecycle Excellence

How Artificial Intelligence is Impacting the MedTech Industry

Etienne Nichols
January 30, 2024
In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable... Read More
MedTech Lifecycle Excellence

Greenlight Guru Finishes 2023 with Strong Momentum in Q4

Jeff Perkins
January 24, 2024
The company continues to acquire large customers and gain accolades for its quality and clinical MedTech solutions. Read More
MedTech Lifecycle Excellence

IVDR: How to Meet the Quality Management System Requirements of a Device

Enrico Perfler
January 18, 2024
When we talk about a Quality Management System (QMS), we refer to the set of all processes related to the creation of a product/service, from planning, design, and... Read More
MedTech Lifecycle Excellence

Fundamentals of Quality & Regulatory

Etienne Nichols
January 18, 2024
In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Read More
Regulatory Submission

Navigating Clinical Evaluations and Investigations in MedTech

Helene Quie
January 12, 2024
In an era where technological advancements and regulatory requirements are constantly evolving, the MedTech industry faces the critical challenge of enhancing both safety and... Read More
MedTech Lifecycle Excellence

The State of AI & Clinical Investigations

Etienne Nichols
January 11, 2024
In a today's conversation on the Global Medical Device Podcast, host Etienne Nichols engages with Dr. Maria Nyakern on the burgeoning integration of AI in medical devices. Read More
MedTech Lifecycle Excellence

How PLM and QMS Solutions Work Together in MedTech

Tory Lopez
January 10, 2024
A quality management system (QMS) and a product lifecycle management (PLM) system are closely related parts of the tech stack at many modern MedTech companies. Read More
MedTech Lifecycle Excellence

The Evolving Landscape of AI in MedTech

Etienne Nichols
January 4, 2024
In this insightful episode, Eric Henry and Etienne Nichols delve into the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in... Read More
Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
Getting a medical device to market is a huge accomplishment for any MedTech company. Design and development, regulatory approval, supplier management and manufacturing,... Read More
MedTech Lifecycle Excellence

Climbing the MedTech Career Ladder - How to Get to the Top

Etienne Nichols
December 21, 2023
In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Read More
MedTech Lifecycle Excellence

Greenlight Guru’s MedTech Suite Named a Leader in G2 Winter 2024 Grid Report

Jeff Perkins
December 19, 2023
Greenlight Guru Quality continues to be recognized as the #1 Medical QMS in the industry while Greenlight Guru Clinical becomes a leader in the EDC category. Read More
MedTech Lifecycle Excellence

Customers Rank Greenlight Guru Quality as Medical QMS Leader in G2 Winter 2024 Report

Jeff Perkins
December 17, 2023
Greenlight Guru is honored to announce that it has been selected by users as a leading QMS vendor for the twentieth consecutive quarter in G2’s Winter 2024 Grid Report, as... Read More
MedTech Lifecycle Excellence

Greenlight Guru Clinical: Leader in the EDC Category in G2 Winter 2024 Grid Report

Páll Jóhannesson
December 17, 2023
Greenlight Guru Clinical, a leader in MedTech's clinical data collection, has received a significant accolade in G2's Winter 2024 rankings, particularly shining in the... Read More
Product Development

Most Popular Medical Device Content in 2023

Tory Lopez
December 15, 2023
2023 was a busy and exciting year here at Greenlight Guru. Over the past 12 months, we’ve been listening closely to our customers, innovating our products, and winning... Read More
MedTech Lifecycle Excellence

Considerations for IVD

Etienne Nichols
December 14, 2023
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima... Read More
MedTech Lifecycle Excellence

Moving MedTech Forward: Greenlight Guru’s 2023 in Review

Greenlight Guru
December 12, 2023
2023 was a year of growth, learning, and excitement here at Greenlight Guru. Whether it was releasing new product features, launching the MedTech Suite, winning industry... Read More
Product Development

Top 40+ Medical Device Contract Research Organizations (CROs)

Páll Jóhannesson
December 8, 2023
In the rapidly evolving MedTech industry, companies encounter numerous challenges while striving to bring devices to market. Read More
MedTech Lifecycle Excellence

Human-Centered Design in Medical Devices

Etienne Nichols
December 7, 2023
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Morven Shearlaw, co-founder of Fearsome, in a thought-provoking discussion... Read More
Post-Market Surveillance

Electronic Data Capture (EDC) Buyer’s Guide: Making the Business Case for a New EDC System

Páll Jóhannesson
December 6, 2023
Whether you’ve got a new clinical trial on the horizon, or you’re just fed up with the limitations of the way you’re currently capturing clinical data, you’ve probably got a... Read More
MedTech Lifecycle Excellence

FDA's eSTAR Program

Etienne Nichols
December 1, 2023
This episode of the Global Medical Device Podcast delves into the world of FDA submissions, specifically focusing on the eSTAR program. Read More
MedTech Lifecycle Excellence

AI, Automation, and Risk in MedTech

Tyler Foxworthy
November 29, 2023
Most of us are quite comfortable using automations in both our personal and work lives. So much so that we barely think of them as automations anymore. Read More
MedTech Lifecycle Excellence

A Better Way to Develop A Medical Device with Digital and Physical Elements (Part 2 of 2)

Ken Soliva
November 28, 2023
InPart 1of this two-part blog post series, we explained why next-generation medical devices with hardware/software interactions need a new, holistic... Read More
MedTech Lifecycle Excellence

A Better Way to Develop a Medical Device with Digital and Physical Elements (Part 1 of 2)

Ken Soliva
November 28, 2023
InPart 1of this blog post series, we explain why next-generation medical devices with hardware/software interactions need a new, holistic development methodology. Read More
MedTech Lifecycle Excellence

Using AI in MedTech

Etienne Nichols
November 22, 2023
In this episode, we delve into the burgeoning world of artificial intelligence in MedTech. Read More
Establishing a QMS

The Ugly Truth About Managing Design Controls on Spreadsheets

Etienne Nichols
November 20, 2023
At one point in my career, after managing the design controls and risk management documentation, I decided to move on. Read More
MedTech Lifecycle Excellence

Becoming an Advisor to a Medical Device Company

Etienne Nichols
November 16, 2023
In this episode, we delve into the multifaceted aspects of advisory roles within medical device startups. Read More
Establishing a QMS

Enterprise Quality Management Software: What You Need To Know

Etienne Nichols
November 14, 2023
A quality management system (QMS) is simply a formalized system for documents, policies, procedures, and processes that companies in many industries—including MedTech—use to... Read More
Regulatory Submission

Recent FDA Draft Guidances

Etienne Nichols
November 9, 2023
In this episode, we dissect the evolving landscape of FDA medical device regulations with regulatory expert Mike Drues. Read More
Product Development

Ultimate Guide to Supplier Management for Medical Device Companies

Ben Bancroft
November 8, 2023
A medical device is only as good as its parts. Read More
MedTech Lifecycle Excellence

The AI in MedTech Trend Report 2023 Is Here

Jeff Perkins
November 7, 2023
At Greenlight Guru, when we want to know exactly what’s happening in the MedTech industry, we like to go to the source: the medical device professionals who work every day to... Read More
MedTech Lifecycle Excellence

Greenlight Guru Releases The AI in MedTech Trend Report 2023

Greenlight Guru
November 7, 2023
The survey of more than 200 medical device professionals is a snapshot into the interest and attitudes toward AI tools and their adoption in the MedTech industry. Read More
Establishing a QMS

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

Jon Speer
November 3, 2023
The CAPA process is a frequent topic of discussion here at Greenlight Guru, mainly because it’s still such a big issue for medical device companies. Year after year, CAPA... Read More
Regulatory Submission

Planning an FDA Submission

Etienne Nichols
November 2, 2023
In this episode, Etienne Nichols and Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dive deep into the... Read More
Establishing a QMS

Benefits of Switching from MasterControl to Greenlight Guru

Etienne Nichols
November 2, 2023
At Greenlight Guru, we pride ourselves on building products specifically for MedTech companies. With more than 1,100 customers worldwide, we take our mission to move MedTech... Read More
MedTech Lifecycle Excellence

Reducing Medical Device Risk with Usability Testing: The Why, the How, and the Who

Delve
November 1, 2023
Industry research shows that each year, approximately 400,000 hospitalized patients experience some kind of preventable harm. Read More
Product Development

Ultimate Guide to Software as a Medical Device (SaMD)

Wade Schroeder
October 30, 2023
Only recently has the medical device industry began designing software-based products that have no direct relationship to hardware devices at all. Read More
Establishing a QMS

Top 7 QMS Tools for MedTech (Plus 4 Bonus Resources)

Etienne Nichols
October 27, 2023
The FDA’s Quality System Regulation (QSR) and ISO 13485:2016 both lay out requirements for a medical device manufacturer’s QMS. (The two will soon be harmonized, but that’s... Read More
MedTech Lifecycle Excellence

What NOT to say to FDA

Etienne Nichols
October 26, 2023
In this comprehensive episode, Etienne Nichols and Mike Drues dive into the enlightening world of FDA inspections. Read More
Product Development

Ultimate Internal Audit Checklist: FDA QSR & ISO 13485 Audit Checklist

Etienne Nichols
October 25, 2023
It was nothing more than a checklist that saved $175 million and 1,500 lives. Read More
MedTech Lifecycle Excellence

Greenlight Guru Expands Market Leadership with Strong Momentum in Q3 2023

Jeff Perkins
October 24, 2023
The company continues to rapidly acquire large customers as its software continues to set the industry standard for quality and clinical MedTech solutions. Read More
Product Development

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

Jesseca Lyons
October 20, 2023
What is IQ, OQ, PQ? These are the abbreviations we use in the medical device industry for the three steps of process validation: Installation Qualification (IQ), Operational... Read More
Establishing a QMS

IVDR for In Vitro Diagnostic Medical Device Companies - Ultimate Guide

Laura Maher
October 20, 2023
The global medical device industry is a space where forward thinking meets problem solving, all for the same purpose: to improve the quality of life. However, if you’re going... Read More
Establishing a QMS

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

Etienne Nichols
October 20, 2023
On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulation (QMSR). Read More
Product Development

5 Foundational Steps of a CAPA Quality Process

Etienne Nichols
October 19, 2023
I have a bold opinion: The corrective and preventive action (CAPA) process is the 2nd-most important component of your quality management system (QMS). Read More
MedTech Lifecycle Excellence

Understanding LDTs & the FDA Proposed Ruling

Etienne Nichols
October 19, 2023
In this episode, host Etienne Nichols and Shannon Bennett, a regulatory affairs expert in the diagnostic testing space dive into the FDA's proposed rules for Laboratory... Read More
Establishing a QMS

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

Etienne Nichols
October 17, 2023
Read More
Regulatory Submission

EU MDR - 9 Top Questions Answered (European MDR)

Etienne Nichols
October 17, 2023
What is EU MDR? The European Medical Device Regulation (EU MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and... Read More
Product Development

FDA Proposes New Rule to Regulate LDTs as IVDs: Here’s What’s at Stake

Etienne Nichols
October 13, 2023
On October 3, 2023, the Food and Drug Administration (FDA) published a proposed rule seeking to amend FDA’s regulations to bring Laboratory Developed Tests (LDTs) under the... Read More
MedTech Lifecycle Excellence

UDI and EUDAMED: Past, Present and Future State

Etienne Nichols
October 12, 2023
In this episode, we discuss the past, present, and future state of EUDAMED. EUDAMED is the European Database for Medical Devices, and is part of the European Medical Device... Read More
Regulatory Submission

MHRA Guidance Document on Clinical Investigations in UK

Stephanie Hinton
October 10, 2023
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the agency that regulates medical devices and in vitro diagnostics, as well as clinical... Read More
Product Development

Guide to Understanding AI Applications that Drive Business Value in MedTech

Tyler Foxworthy
October 6, 2023
Greenlight Guru recently surveyed more than 200 MedTech professionals to find out whether they were using AI in their work and what they thought about its potential to help... Read More
MedTech Lifecycle Excellence

Selecting a Site for Your Clinical Trial

Etienne Nichols
October 5, 2023
In this episode, we discuss how to select a site for a clinical trial. Read More
Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

Jon Speer
October 2, 2023
Read More
MedTech Lifecycle Excellence

Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

Etienne Nichols
September 21, 2023
In this riveting episode of the Global Medical Device Podcast, Etienne Nichols brings together the dynamic leaders from Greenlight Guru: David DeRam (internally known as DD)... Read More
Establishing a QMS

Greenlight Guru Celebrates 10 Years by Introducing its Multi-Product MedTech Suite

Greenlight Guru
September 19, 2023
The software company is expanding its product offering to meet the evolving needs of the medical device industry. Read More
Regulatory Submission

Ultimate Guide to Device Class Requirements under EU MDR

Laura Court
September 19, 2023
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More
Product Development

Introducing The Greenlight Guru MedTech Suite: A Comprehensive Set Of Industry-Specific Solutions

Jeff Perkins
September 18, 2023
Across the globe, visionaries and innovators are building the future of medical devices that improve the quality of life for millions of people. Read More
Product Development

How To Approach Supplier Corrective Action Requests (SCAR)

Taylor Brown
September 15, 2023
For medical device manufacturers, finding success means setting ourselves up for success with repeatable processes that not only ensure quality, but also mitigate future risk. Read More
featured

Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
Clinical investigations play an important role in your journey of bringing a medical device to market. While they are often perceived as difficult and complex, having a good... Read More
MedTech Lifecycle Excellence

From Academia to FDA Clearance (True Quality Roadshow - Boston)

Etienne Nichols
September 14, 2023
In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their... Read More
Product Development

Engineering Change Order: Its Role in the Change Management Process

Jesseca Lyons
September 14, 2023
Change is just part of life for medical device companies. No device makes it to market without quite a few changes to its design along the way, and even devices already on... Read More
Product Development

5 Tips for Medical Device Registration across Global Markets

Etienne Nichols
September 14, 2023
You have compiled all of the necessary documentation for your regulatory submission, submitted it to the appropriate regulatory body, and received the much-anticipated news... Read More
Establishing a QMS

Greenlight Guru Yet Again Ranked as a Leader in QMS and Medical QMS Categories in G2 Fall 2023 Grid Reports

Etienne Nichols
September 13, 2023
The leaves may be starting to change, but one thing you can count on staying the same is G2 ranking Greenlight Guru as a Leader in both the QMS and Medical QMS Grid® Reports. Read More
Post-Market Surveillance

How to Structure a Clinical Investigation Report (CIR) Summary

Stephanie Hinton
September 8, 2023
If you’re conducting a clinical investigation of a medical device in an EU Member State, you will be required to submit a clinical investigation report (CIR) along with a... Read More
Regulatory Submission

Accelerating SaMD Development in a Compliant Agile Way

Etienne Nichols
September 7, 2023
In this episode, we explore the impact of software development methodologies in the medical device industry. Read More
Product Development

Creating a Supplier Scorecard for Medical Device Supplier Management

Ben Bancroft
September 6, 2023
A supplier scorecard is one of the most effective tools medical device manufacturers have for assessing the performance of their suppliers. Read More
Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Etienne Nichols
September 1, 2023
Read More
Establishing a QMS

What is a Predetermined Change Control Plan (PCCP) and Who Needs One?

Etienne Nichols
September 1, 2023
In April 2023, FDA published a new draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning... Read More
Regulatory Submission

MedTech Funding and Preparing for Due Diligence

Etienne Nichols
August 31, 2023
Join guest Devon Campbell as we discuss MedTech funding in this episode of the Global Medical Device Podcast. He unveils startup red flags, from data integrity to product... Read More
Regulatory Submission

Exploring Breakthrough Device Designation

Etienne Nichols
August 25, 2023
In this episode of the Global Medical Device Podcast, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. Read More
Product Development

3 Tips for Adding Flexibility to Your MedTech Manufacturing Supply Chain

Etienne Nichols
August 25, 2023
Supply chain management is crucial to any MedTech company’s ability to deliver safe, effective, and high-quality devices to their customers. Read More
Product Development

What is the FDA Medical Device Registration Process?

Laura Court
August 22, 2023
To patients and providers, medical devices are more than a product. They serve as the conduit to better quality of life for patients, improve diagnostic speed and accuracy,... Read More
Product Development

Machine Learning, AI and Risk Management: TIR34971 Explained

Etienne Nichols
August 18, 2023
TIR34971:2023, Application of ISO 14971 to machine learning in artificial intelligence, was published in March 2023. Read More
MedTech Lifecycle Excellence

Regulatory Strategy and the Advantage of Diversity in MedTech

Etienne Nichols
August 17, 2023
In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Read More
Post-Market Surveillance

How to Comply with HIPAA and EU GDPR in Medical Device Studies

Chris Rush
August 17, 2023
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the US and the EU have regulations in place... Read More
MedTech Lifecycle Excellence

Greenlight Guru Invests in State-of-the-Art Arena and Training Facility That Aims to Help Youth Basketball Players On and Off the Court

Jeff Perkins
August 15, 2023
The software company is making a significant charitable investment to improve the quality of life for young athletes. Read More
Establishing a QMS

Conducting Quality Investigations in Medical Device Manufacturing

Etienne Nichols
August 11, 2023
When a quality event, like a product or process nonconformance, occurs in the manufacturing of medical devices, there’s a chance that the safety and efficacy of any affected... Read More
MedTech Lifecycle Excellence

28 Days To Save The World - True Quality Roadshow

Etienne Nichols
August 10, 2023
During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Read More
Establishing a QMS

Omnibus Act Impact on Medical Device Cybersecurity

Naomi Schwartz
August 7, 2023
The ‘‘Consolidated Appropriations Act, 2023’’ (H.R. 2617) was passed by the U.S. Senate and signed into law by President Biden on December 29, 2022. Read More
Post-Market Surveillance

Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting

Páll Jóhannesson
August 4, 2023
The latest Greenlight Guru Clinical update includes a newly designed Reporting module that streamlines clinical data management for scaling medical device companies. By... Read More
MedTech Lifecycle Excellence

3P510k: What Is a 510k 3rd Party Review & What are the Benefits?

Etienne Nichols
August 3, 2023
In today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. Read More
MedTech Lifecycle Excellence

The Right Way to Start a QMS: When, How, & What

Etienne Nichols
July 28, 2023
Most people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start,... Read More
MedTech Lifecycle Excellence

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

Etienne Nichols
July 20, 2023
In April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine... Read More
MedTech Lifecycle Excellence

Greenlight Guru Continues Strong Growth in Q2 2023 Powered by Product Innovation

Jeff Perkins
July 18, 2023
The company’s recent product launches have helped fuel continued success as large global MedTech companies adopt its solutions. Read More
Product Development

How to Improve Detecting, Correcting, and Preventing Nonconformances

Etienne Nichols
July 17, 2023
If you work at a MedTech company, nonconformances are a fact of life. As long as there is still a human element in the development and manufacture of medical devices, there... Read More
Establishing a QMS

Ultimate List of ISO Standards for Medical Devices

Tom Rish
July 14, 2023
The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for numerous... Read More
MedTech Lifecycle Excellence

The Role of dFMEA in Risk Management for Medical Devices

Etienne Nichols
July 12, 2023
How do dFMEA and ISO 14971 work together? This topic is controversial but essential, and today’s guest is more than capable of tackling it. Risk management is one of the top... Read More
MedTech Lifecycle Excellence

Understanding the ROI of an eQMS

Etienne Nichols
July 11, 2023
In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Read More
MedTech Lifecycle Excellence

CSA vs. CSV: Modern Validation for Modern MedTech

Etienne Nichols
July 7, 2023
In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in... Read More
Establishing a QMS

eQMS Buyer’s Guide: Making the Business Case for a New QMS Solution

Etienne Nichols
July 6, 2023
You know you need a new QMS solution. You may even have your sights set on an eQMS that you’ve evaluated and believe is the best option for your organization. Read More
Product Development

Identifying and Evaluating Medical Device Importers

Etienne Nichols
July 3, 2023
Expanding into new foreign markets is an exciting chapter for any medical device manufacturer. Read More
Regulatory Submission

Writing a Clinical Investigation Plan (CIP): The Essential Guide

Stephanie Hinton
June 30, 2023
A clinical investigation plan (CIP) is an essential part of any medical device clinical trial. The CIP is a standalone document that includes everything investigators and... Read More
MedTech Lifecycle Excellence

Management Responsibility: The most important part of a QMS

Etienne Nichols
June 29, 2023
Management responsibility is crucial to the success of a QMS… but what is it? What’s covered by the topic of management responsibility and who’s the responsible party? In... Read More
Establishing a QMS

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

Etienne Nichols
June 25, 2023
As a medical device company, you are expected to deliver innovative, life-changing medical device(s) while ensuring compliance and achieving true quality. This task bears... Read More
Product Development

How to Develop a Risk-Based Approach to Supplier Management

Etienne Nichols
June 18, 2023
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your... Read More
Establishing a QMS

Customers Rank Greenlight Guru Leader in QMS and Medical QMS Software in G2 Grid Reports for Summer 2023

Etienne Nichols
June 18, 2023
We are honored to announce that users have once again selected Greenlight Guru as a leading QMS vendor for the nineteenth consecutive quarter in G2’s Summer 2023 QMS Grid... Read More
MedTech Lifecycle Excellence

The Combination Products Handbook

Etienne Nichols
June 15, 2023
Combination products are a difficult niche because they combine so many different elements. However, today’s guest literally wrote the book on the topic, and she’s joining... Read More
Post-Market Surveillance

Alternatives to PMCF Clinical Investigations

Jon Bergsteinsson
June 15, 2023
Post-Market Clinical Follow-up (PMCF) is necessary for maintaining medical device regulatory compliance in the EU. PMCF Studies are commonly mentioned throughout the EU MDR... Read More
Establishing a QMS

15 Reasons Why Medical Device Companies Choose Greenlight Guru

Etienne Nichols
June 12, 2023
MedTech companies are not just companies—they’re innovators building the medical devices that are saving and improving our quality of life. But, bringing life-changing... Read More
Product Development

How to Manage Complex Downstream Design Changes to Your Medical Device

Etienne Nichols
June 11, 2023
It would be nice if every device your company ever produced got to remain on the market for decades, completely unchanged. Read More
Product Development

Purpose-Built QMS vs General-Purpose QMS: What You Can Expect From Each

Etienne Nichols
June 8, 2023
Just like the tools at your local hardware store, quality management software comes in many shapes and sizes. Read More
MedTech Lifecycle Excellence

Leaning into Lean Documentation

Etienne Nichols
June 7, 2023
What is lean documentation and how can you achieve it? Our guest on today’s live podcast is an expert on quality management systems, audits, and most importantly for today’s... Read More
MedTech Lifecycle Excellence

Greenlight Guru Publishes Independent Study Showing the ROI of eQMS Solutions on MedTech Companies

Greenlight Guru
June 6, 2023
New research demonstrates how modern solutions can significantly improve speed and efficiency while reducing risk for medical device companies.. Read More
Clinical Data Collection

How to Plan and Budget for MedTech Clinical Activities

Jon Bergsteinsson
June 5, 2023
For years, medical device manufacturers have treated clinical data as a regulatory burden—a low-priority obligation that doesn’t garner much attention. Why? It’s primarily... Read More
Product Development

CSV vs. CSA: Exploring FDA’s New Software Validation Approach

Jesseca Lyons
June 4, 2023
In September of 2022, FDA issued a new draft guidance on software validation: Computer Software Assurance for Production and Quality System Software. Read More
Establishing a QMS

Making the Business Case for an eQMS Solution for Your Company

Jeff Perkins
June 2, 2023
As a MedTech Quality professional, you know that you need an eQMS solution. Working in a legacy or paper-based system can significantly impact your team’s overall speed and... Read More
MedTech Lifecycle Excellence

Cybersecurity and the Future of MedTech

Etienne Nichols
June 2, 2023
The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to the Food... Read More
MedTech Lifecycle Excellence

Greenlight Guru Modernizes Validation Approach to Streamline Software Implementation and Adoption for Medical Device Companies

Greenlight Guru
June 1, 2023
The risk-based approach to software validation will help customers efficiently and effectively assure compliance when implementing Greenlight Guru software. Read More
Product Development

Managing Major Changes to Medical Device Packaging

Etienne Nichols
May 29, 2023
Charles Darwin famously said, “It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change.”... Read More
Regulatory Submission

5 Tips for Designing a Medical Device Study Under FDA Requirements

Páll Jóhannesson
May 26, 2023
Let’s face it—medical device clinical studies are no walk in the park. There are so many variables to consider, such as patient recruitment, study design, and regulatory... Read More
Product Development

What is a Modern QMS?

Etienne Nichols
May 26, 2023
For medical device companies, the role of the quality management system (QMS) has greatly evolved—in both form and function. Read More
Establishing a QMS

2023 Greenlight Guru True Quality Roadshow: San Jose Recap

Greenlight Guru
May 24, 2023
Yes way, San Jose! On April 20th, the Greenlight Guru True Quality Roadshow landed in San Jose, California for its second stop of the 2023 tour. Unsurprisingly, the Bay Area... Read More
Product Development

4 Tips for Managing Your MedTech Portfolio

Etienne Nichols
May 24, 2023
There’s no doubt that MedTech is a noble industry, built on the mission of improving the quality of life with impactful medical devices. Read More
MedTech Lifecycle Excellence

Ad Promo and The Difference in Regulatory & Legal

Etienne Nichols
May 24, 2023
What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it comes to... Read More
Post-Market Surveillance

How To Use FDA’s Guidance on Post-Approval Studies During Premarket Approval

Jon Bergsteinsson
May 24, 2023
In the US, post-market clinical studies are not required of every medical device manufacturer. However, FDA does have the authority to order post-market surveillance of any... Read More
MedTech Lifecycle Excellence

How AI Can Help You Manage Risk

Etienne Nichols
May 17, 2023
With the advent of new Artificial Intelligence (AI) tools, where is risk management headed? How are they affected by the changes? Risk management is essential and becoming... Read More
Product Development

The Risk Management + Design Controls Connection: What Device Makers Need to Know

Etienne Nichols
May 16, 2023
Medical devices are intended to save and improve quality of life. Read More
Product Development

How To Vet Medical Device Distributors in Multiple Markets

Ben Bancroft
May 15, 2023
The majority of medical device companies, even the relatively big ones, will need third-party distributors to get their devices to market. Read More
Product Development

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

Niki Price
May 14, 2023
The medical device risk management process relies heavily on the use of documentation. Whether the activity is conducted onsite or offsite, during design or after... Read More
Clinical Data Collection

The Tools that Make Clinical Investigations

Etienne Nichols
May 12, 2023
What makes a clinical investigation run smoothly? In today’s conversation, you’ll hear from Jon Bergsteinsson as we speak about electronic data capture for clinical... Read More
Regulatory Submission

7 Tips for FDA 21 CFR Part 11 Compliance

Etienne Nichols
May 12, 2023
When it comes to regulatory requirements for medical device companies, there can be some confusion around FDA 21 CFR Part 11 compliance. Read More
Product Development

eIFU Requirements: Everything You Need to Know About Electronic Instructions for Use

Etienne Nichols
May 11, 2023
It doesn’t matter how well-engineered or high-quality your medical device is; you still need to make sure people know how to use it. Read More
Establishing a QMS

Understanding ISO 14971 Medical Device Risk Management

Etienne Nichols
May 11, 2023
Medical device companies MUST have established risk management processes that comply with ISO 14971. Read More
Establishing a QMS

5 Dos and Don'ts when Choosing a QMS Solution for Your Medical Device Company

Etienne Nichols
May 10, 2023
As a medical device manufacturer, your quality management system (QMS) is the heart of your operations. Read More
MedTech Lifecycle Excellence

Introducing Risk Solutions: A New Era in Risk Management for MedTech

Greenlight Guru
May 9, 2023
In our day-to-day lives, most of us manage risk in a pretty haphazard fashion. Decisions to put on a seatbelt or reapply sunscreen after a few hours on the beach aren’t made... Read More
MedTech Lifecycle Excellence

Greenlight Guru Launches AI-Powered Solutions to Enable Better Risk Management for the MedTech Industry

Greenlight Guru
May 9, 2023
First-of-its-kind Risk Solutions pairs AI-generated insights with the only intuitive and ISO 14971:2019 compliant risk management software to help medical device companies... Read More
Post-Market Surveillance

How to use the Greenlight Guru Clinical AE/SAE reporting module

Páll Jóhannesson
May 8, 2023
This blog post highlights the ready-to-use Greenlight Guru Clinical module for Adverse Events (AE) and Serious Adverse Events (SAE). Let’s dive into how the reporting module... Read More
Product Development

Planning Your Medical Device Global Market Regulatory Strategy

Etienne Nichols
May 5, 2023
A regulatory strategy is more than just picking a pathway to market. It’s an in-depth process by which you choose the best markets and pathways not only for your device, but... Read More
MedTech Lifecycle Excellence

Complaint Handling with Medical Device Guru, Brittney McIver

Etienne Nichols
May 3, 2023
What would you think about dealing with complaints all day? Today’s guest has some ideas. Brittney McIver is a Medical Device Guru at Greenlight Guru where she helps guide... Read More
Clinical Data Collection

Why Clinical Data Is Essential to Value-Based Healthcare

Páll Jóhannesson
May 1, 2023
The healthcare industry in many countries is undergoing a transition. We’re moving away from a strict focus on the upfront cost of care to what’s known as “value-based”... Read More
Product Development

3 Things to Love about Internal Audits

Sara Adams
April 28, 2023
I have a confession to make—I love audits. I mean, I really love audits. Read More
MedTech Lifecycle Excellence

HTEC Group Partners with Greenlight Guru to Accelerate Time-to-Market for Medical Device Companies

Greenlight Guru
April 27, 2023
Expanded partnership will galvanize MedTech companies’ push to improve the quality of life. Read More
MedTech Lifecycle Excellence

Avoiding Potential Issues with your 510(k) Submission

Etienne Nichols
April 27, 2023
When bringing a medical device to the market, it’s important to be aware of the fatal 510(k) flaw. In today’s episode, Mike Drues joins the podcast to discuss the potential... Read More
Product Development

4 Advantages of an eQMS Over a Paper-Based QMS

Etienne Nichols
April 21, 2023
One of the biggest factors that determines a medical device company’s success is how effectively they manage quality processes. Read More
MedTech Lifecycle Excellence

Meet a Guru: Brittani Smith

Etienne Nichols
April 20, 2023
What’s it like to become a Medical Device Guru? In today’s episode, you’ll meet one of our newer Gurus, Brittani Smith, and find out more about her role and journey working... Read More
Post-Market Surveillance

How to Use Clinical Data in Medical Device Submissions in the EU & US

Jon Bergsteinsson
April 20, 2023
Bringing medical devices to market is still harder than it should be. Obtaining regulatory approval for medical devices is a rigorous process that involves submitting... Read More
MedTech Lifecycle Excellence

Greenlight Guru Builds Strong Momentum in Q1 2023 as Medical Device Companies Move to Modern Digital Solutions

Greenlight Guru
April 19, 2023
The company’s QMS and EDC solutions have become the preferred choice for global MedTech companies. Read More
Regulatory Submission

4 Reasons to Stop Mixing Your Clinical Data Collection Methods

Páll Jóhannesson
April 17, 2023
They say that variety is the spice of life—but when it comes to blending clinical data collection tools, it’s more like dumping the whole spice rack in the pot. One of the... Read More
Establishing a QMS

How To Avoid a Failed QMS Implementation

Taylor Brown
April 16, 2023
No one implements a new QMS just for fun. Read More
Establishing a QMS

5 Steps for Getting your CE Marking with EU MDR Requirements

Tom Rish
April 14, 2023
It has long been thought that the quickest path to market for medical device manufacturers is to access the European market by obtaining a CE marking instead of going through... Read More
MedTech Lifecycle Excellence

Why Building Supplier Relationships Is So Important

Etienne Nichols
April 12, 2023
Read More
Establishing a QMS

2023 Greenlight Guru True Quality Roadshow: Houston Recap

Greenlight Guru
April 12, 2023
Thank you, Houston! The 2023 True Quality Roadshow got off to an exciting start on March 9th, as Greenlight Guru, along with sponsors Velentium and Rook Quality Systems,... Read More
Post-Market Surveillance

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

Etienne Nichols
April 10, 2023
The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipulated by the European Union Medical Device Regulation (EU MDR). Read More
Product Development

Can dFMEA and ISO 14971 Co-Exist in Medical Device Risk Management?

Etienne Nichols
April 9, 2023
Risk management is a notoriously complex subject—one that many people (including yours truly) have strong feelings about. Read More
Establishing a QMS

“A Perfect eQMS”: Customers Rank Greenlight Guru #1 QMS in G2 Spring 2023 QMS Grid Report

Etienne Nichols
April 6, 2023
Greenlight Guru is honored to announce that it has been selected - by users - as the leading QMS for the eighteenth consecutive quarter in G2’s Spring 2023 QMS Grid Report. Read More
MedTech Lifecycle Excellence

Systematic Literature Review for EU MDR

Etienne Nichols
April 5, 2023
What’s involved in a systematic literature review for the EU MDR, and how should companies handle those steps? In today’s episode, you’ll hear from Co-Founder and Operating... Read More
Clinical Data Collection

ePRO vs Paper: The Debate Over Patient Reported Outcomes Is Over

Jon Bergsteinsson
April 5, 2023
Patient-reported outcomes (PRO) are becoming increasingly important to medical device clinical trials. Your regulatory strategy, reimbursement strategy, marketing, and more... Read More
MedTech Lifecycle Excellence

From Closed to Connected: Share Data & Unlock Efficiencies with Greenlight Guru’s Export API

Greenlight Guru
April 4, 2023
Take a moment to recognize how much meaningful data lives in your Quality Management System (QMS), spanning multiple processes across quality, product development,... Read More
MedTech Lifecycle Excellence

Greenlight Guru Introduces Export API for a Connected Quality Management System

Greenlight Guru
April 4, 2023
MedTech companies can now connect quality system data with other third-party software. Read More
Product Development

eBOM vs mBOM: What’s the Difference?

Niki Price
March 31, 2023
A bill of materials (BOM) contains all the materials and parts required to build your device, as well as directions for how to use them and where to acquire them. Read More
Post-Market Surveillance

Medical Device Adverse Event Reporting Regulations: EU vs. US

Páll Jóhannesson
March 31, 2023
Regulatory authorities in both Europe and the United States require medical device companies to report on some adverse events (AEs) that occur during clinical investigations. Read More
Product Development

5 Tips for Running Effective Internal Quality Audits

Etienne Nichols
March 31, 2023
How did your last internal quality audit go? Internal audits can be a bit of a scramble for some medical device companies. Read More
MedTech Lifecycle Excellence

Building Your Design Controls (and Pitfalls to Avoid)

Etienne Nichols
March 29, 2023
What do engineers need to understand about manufacturing? How can you apply that knowledge to design controls? On today’s episode, our guest Tom Rish covers the topic of... Read More
Product Development

How to Handle Medical Device Adverse Events

Etienne Nichols
March 24, 2023
Medical device adverse events can be a daunting challenge for any manufacturer to address. Read More
Clinical Data Collection

Electronic Data Capture Systems vs. Paper-based Data Collection

Jon Bergsteinsson
March 24, 2023
In this blog, we’ll be comparing electronic data capture (EDC) systems to paper-based data collection systems. To do so, we’ll be reviewing four independent studies: ... Read More
MedTech Lifecycle Excellence

Most Common Problems Found During FDA Inspections in 2022

Etienne Nichols
March 23, 2023
Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Michael Drues, PhD joins the podcast to talk about the FDAs... Read More
Product Development

Explaining IVDR Classification for In Vitro Medical Devices

Wade Schroeder
March 23, 2023
What is IVDR? The In Vitro Diagnostic Regulation (IVDR) is a European Union regulation applicable to in vitro diagnostic medical devices. It establishes a risk-based... Read More
Product Development

Complete Guide to Bringing a Medical Device to Market

Tom Rish
March 20, 2023
Read More
Product Development

Making the BOM & Design Controls Connection

Niki Price
March 19, 2023
Your bill of materials (BOM) is a comprehensive list of all the materials and parts required to build your device, as well as directions for how to use them and where to... Read More
Establishing a QMS

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

Etienne Nichols
March 17, 2023
One of the most critical decisions a MedTech company will make is choosing the right quality management system (QMS) solution. The QMS solution you choose will have a... Read More
Product Development

The Ultimate Guide To Design Controls For Medical Device Companies

Jon Speer
March 17, 2023
Read More
Clinical Data Collection

Clinical Data Management System (CDMS) for Medical Device Clinical Trials

Páll Jóhannesson
March 16, 2023
What is Clinical Data Management? For MedTech firms running clinical investigations on medical devices, clinical data management is the process of collecting and managing... Read More
Product Development

V&V Activities from a Verification Engineer POV - How Hard Could It Be?

Etienne Nichols
March 15, 2023
Read More
Clinical Data Collection

Everything You Need to Know about Electronic Data Capture (EDC) for Clinical studies

Páll Jóhannesson
March 15, 2023
The purpose of a clinical investigation (or clinical study) is to determine the safety and effectiveness of a novel treatment, such as a medical device. Biostatisticians make... Read More
Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

Etienne Nichols
March 13, 2023
The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union. Read More
Product Development

Top 40 IMDRF Technical Documents for Medical Devices

Etienne Nichols
March 10, 2023
The International Medical Device Regulators Forum (IMDRF) is a global organization on a mission—a mission to enhance the safety and quality of medical devices and promote... Read More
MedTech Lifecycle Excellence

Understanding the 'Compliance Manager' Role

Etienne Nichols
March 8, 2023
What are the challenges in managing compliance and the difference between compliance and quality management positions? You’ll learn more by listening to today’s guest. Read More
Clinical Data Collection

Complying with Good Clinical Practice in Clinical Data Collection

Jon Bergsteinsson
March 8, 2023
For medical device manufacturers, clinical data is more than a collection of numbers and statistics—it’s a snapshot of the lives of patients you’re trying to help. And while... Read More
Product Development

Medical Device Classification Guide - How To Determine Your Device Class

Etienne Nichols
March 7, 2023
What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach to determining how... Read More
Product Development

How to Define User Needs During Design Controls

Etienne Nichols
March 3, 2023
Every medical device begins with the same purpose—to improve the quality of life by meeting the needs of its users. Read More

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