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

3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers

By Wade Schroeder on September 6, 2021

Software as a Medical Device (SaMD) is a rapidly growing subset of the medical device industry, and ...

Driving Medtech Innovation with Safe and Effective Medical Devices

By Jon Speer on September 3, 2021

In the medical device industry, innovation is a complicated subject.

5 Biggest Quality Mistakes (And How You Can Avoid Making Them)

By Sara Adams on August 29, 2021

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality m...

5 Postmarket Surveillance System Musts for Every EU Manufacturer

By Sara Adams on August 22, 2021

Designing, developing, and getting your medical device approved and onto the market is a huge accomp...

3 Things Med Device Startups Must Do When Implementing a QMS

By Taylor Brown on August 16, 2021

I often hear early-stage medical device companies say they’re not ready for a quality management sys...

Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success

By Nick Tippmann on August 6, 2021

Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare tha...

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...

eQMS in Academia: Practical Learning for Biomedical Engineering Students

By Nick Tippmann on July 28, 2021

Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical devi...

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...

Tips for Running Better Management Reviews

By Nick Tippmann on July 19, 2021

How efficient are your management reviews? Could improvements be made? It might be time to reevaluat...

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