New FDA Guidance - Increasing Transparency for Medical Devices

by PRP Consulting Team on Oct 12, 2021 5:55:22 PM

The FDA by charter has what appears to be a role with contradictory goals when it comes to medical devices:

  • Prevent ineffective and unsafe medical...

What's New in FDA Regulations?

by PRP Consulting Team on Sep 7, 2021 2:08:57 PM


What You Need to Know about SaMD, Artificial Intelligence, and Machine Learning

by PRP Consulting Team on Aug 24, 2021 1:02:20 PM


Coronavirus Impact on EU MDR

by Stefanie Wichansky on Mar 28, 2020 2:07:33 PM

Medical device companies have been scrambling over the past few years to ensure compliance with EU MDR by the mandatory deadline of May 26, 2020. Now...

Latest EU MDR News - Extension for Certain Class I Devices

by Stefanie Wichansky on Feb 11, 2020 1:38:01 PM

In December 2019, the European Parliament approved the second corrigendum of EU MDR. Typically, a corrigendum is comprised of minor corrections to an...

5 Critical Points for Updating CERs

by Stefanie Wichansky on Mar 20, 2019 5:07:13 PM


The new European Union Medical Device Regulation ("EU MDR") represents one of the most significant and impactful regulations within the medical...

EU MDR: 5 Critical Risks of Not Taking Action Now

by Stefanie Wichansky on Mar 19, 2019 8:49:37 AM