Medical Device Quality, Regulatory and Product Development Blog

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...

How to Apply IEC 62304 Requirements for Medical Device Software

By Wade Schroeder on July 18, 2021

If you’re developing a medical device that uses software, or developing SaMD (Software as a Medical ...

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

By Nick Tippmann on July 14, 2021

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device com...

Navigating the MedTech Cybersecurity Ecosystem

By Nick Tippmann on July 12, 2021

Cybersecurity continues to be a crucial concern for medical device safety and effectiveness in the U...

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

By Sara Adams on July 9, 2021

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

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