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

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 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...

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...

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...

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 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 ...

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

By Nick Tippmann on June 14, 2021

What did FDA report as the most-cited issues during medical device inspections for the fiscal year o...

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 ...

Examining the HHS Proposal for Premarket Notification Exemptions

By Nick Tippmann on June 7, 2021

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS...

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

By Jon Speer on May 28, 2021

Would things be simpler in the medical device regulatory space if there was global harmonization acr...

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