<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 150,000+ other medical device professionals outperforming their peers.

Challenges for Regulatory Submission: EU vs. US - Featured Image

Challenges for Regulatory Submission: EU vs. US

What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing w...
Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance - Featured Image

Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance

A Performance Evaluation (PE) is required for any in vitro diagnostic device (IVD) that a manufactur...
Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities - Featured Image

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

The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipul...
Explaining UDI Requirements for GUDID and EUDAMED - Featured Image

Explaining UDI Requirements for GUDID and EUDAMED

Recent numbers from the World Health Organization indicate there are at least 2 million different ty...
Ultimate Guide to Clinical Evaluation of a Medical Device in the EU - Featured Image

Ultimate Guide to Clinical Evaluation of a Medical Device in the EU

How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (Part 4 of 4) - Featured Image

How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (Part 4 of 4)

If you plan on selling a medical device in the European Union, then you should plan on writing a cli...
Everything You Need to Know About Root Cause Analysis - Featured Image

Everything You Need to Know About Root Cause Analysis

At some point, every medical device company will encounter an issue that requires an internal invest...
4 Problems (and Solutions) for the Medical Device Supply Chain - Featured Image

4 Problems (and Solutions) for the Medical Device Supply Chain

If you had told me three years ago that supply chain economics and logistics would become a popular ...
QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices - Featured Image

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the in...
Understanding Technical Documentation in EU Regulations - Featured Image

Understanding Technical Documentation in EU Regulations

Generally speaking, technical documentation is the compilation of documents that explains how a prod...
QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies - Featured Image

QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...
What is the Best Way to Structure a Risk Management File? - Featured Image

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

The medical device risk management process relies heavily on the use of documentation. Whether the a...

The Greenlight Guru Medical Device Blog

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

Our Most Popular Posts

Topics

See More Topics...