On March 29, 2023, Section 3305 of the Consolidated Appropriations Act of 2023, Ensuring Cybersecurity of Medical Devices, (“Section 3305”) became...
EU MDR & IVDR Amendment - Q&A Update
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PRP Consulting Team on Apr 14, 2023 11:31:36 AM
In last month’s blog, we covered the European Council’s (“EC”) amendment which extends the transition deadlines for the certification of medical...
EU MDR & IVDR - Latest Updates
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PRP Consulting Team on Mar 13, 2023 7:06:33 PM
On March 7, 2023, the European Council (“EC”) unanimously approved an extension to the transition deadlines for the certification of medical devices...
New FDA Guidance - Increasing Transparency for Medical Devices
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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?
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PRP Consulting Team on Sep 7, 2021 2:08:57 PM
What You Need to Know about SaMD, Artificial Intelligence, and Machine Learning
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PRP Consulting Team on Aug 24, 2021 1:02:20 PM
Coronavirus Impact on EU MDR
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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....
