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Understanding the FDA Medical Device Classification System - Featured Image

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...
Meet a Guru: Ryan Behringer - Featured Image

Meet a Guru: Ryan Behringer

By Nick Tippmann on July 14, 2021
Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device com...
Cybersecurity for Medical Devices: Best Practices from Regulatory Standards - Featured Image

Cybersecurity for Medical Devices: Best Practices from Regulatory Standards

By Wade Schroeder on July 11, 2021
As more and more medical devices utilizing network connection technology are developed, cybersecurit...
Choosing and Managing Your Medical Device Suppliers - Featured Image

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.
Applying ISO 10993-1 to Medical Device Submission to FDA - Featured Image

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 - Featured Image

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...
Does My Device Labeling Comply with 21 CFR 801? - Featured Image

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 - Featured Image

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.
How the MDSAP Grading System Works - Featured Image

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 MHRA is Regulating Medical Devices in the UK after Brexit - Featured Image

How MHRA is Regulating Medical Devices in the UK after Brexit

By Wade Schroeder on June 11, 2021
If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in ...
Recruiting Top Medical Device Talent in a Competitive Market - Featured Image

Recruiting Top Medical Device Talent in a Competitive Market

By Taylor Brown on June 6, 2021
While robust growth in the medical device industry has seen more people coming into the field, it’s ...
How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation - Featured Image

How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation

By Tom Rish on May 31, 2021
Clinical investigations play an important role in your journey of bringing a medical device to marke...

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