Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases

By Etienne Nichols on August 1, 2021

Too many companies still treat risk management as a “checkbox” activity.

Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification

By Nick Tippmann on July 30, 2021

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...

Understanding the Premarket Approval (PMA) Process

By Tom Rish on July 26, 2021

Before any medical device can hit the US market, FDA must first evaluate the product’s potential ris...

How are Medical Devices Classified under EU MDR?

By Laura Court on July 23, 2021

One of the most important steps in bringing a medical device to market in the European Union (EU) is...

Understanding the FDA Medical Device Classification System

By Ryan Behringer on July 16, 2021

The world of medical devices is one of the most varied and complex industries around today. Innovati...

Choosing and Managing Your Medical Device Suppliers

By Sara Adams on July 9, 2021

Managing your medical device suppliers is a core responsibility of manufacturers.

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...

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.

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 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...

Greenlight Guru Announces Medical Device HQ Partnership

By Nick Tippmann on June 16, 2021

New partnership with training experts will allow the medical device industry’s leading software plat...

Greenlight Guru Receives Strategic Growth Investment from JMI Equity

By Nick Tippmann on June 15, 2021

New investment will allow the medical device industry’s leading software platform to rapidly expand ...

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