Medical Device Quality, Regulatory and Product Development Blog

Managing Clinical Data Activities

By Nick Tippmann on July 7, 2021

Many medical device companies experience challenges with managing clinical trials even in the most i...

Applying ISO 10993-1 to Medical Device Submission to FDA

By Etienne Nichols on July 4, 2021

ISO 10993-1 is the medical device industry’s globally recognized standard for biological evaluation ...

Customers Rank Greenlight Guru Leader in QMS and Medical QMS Software in G2 Grid Reports for Summer 2021

By Nick Tippmann on July 2, 2021

Greenlight Guru is excited to announce that we have been named a leader in G2’s Summer 2021 Grid Rep...

Explaining the Role of Importer under EU MDR

By Nick Tippmann on June 30, 2021

What is the role of the importer, according to EU MDR? The requirements for this role have changed s...

Does My Device Labeling Comply with 21 CFR 801?

By Laura Court on June 28, 2021

Medical device labeling is a core requirement for getting your device onto the market.

Understanding Intended Use from ISO TR 24971:2020

By Jon Speer on June 25, 2021

If you haven’t yet got into ISO TIR 24971:2020, there’s a fair bit to read up on.

Preparing Your Pre-Submission with the Content FDA Wants to See

By Nick Tippmann on June 23, 2021

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...

Centese Trades in Paper-based QMS for Medical Device Success Platform & Achieves 510(k) Clearance

By Nick Tippmann on June 22, 2021

For many early-stage medical device companies, the default option when implementing a quality manage...

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021

By Nick Tippmann on June 21, 2021

What can you still do to help in response to the COVID-19 pandemic? The National Institute of Biomed...

How the MDSAP Grading System Works

By Etienne Nichols on June 18, 2021

The Medical Device Single Audit Program (MDSAP) allows you to have a single audit of your medical de...

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development

By Nick Tippmann on June 16, 2021

Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device ...

Greenlight Guru Announces Medical Device HQ Partnership