Latest on In Vitro Diagnostic Regulations

by PRP Consulting Team on May 3, 2024 4:41:15 PM

On April 25, 2024, the European Commission issued a press release announcing that additional time will be granted to companies to transition to the...

Medical Device Cybersecurity - What's New?

by PRP Consulting Team on Apr 15, 2024 4:16:36 PM

Cybersecurity continues to evolve throughout all facets of the business world, and the medical device industry has taken notice. FDA has published...

Artificial Intelligence Act - What You Need to Know

by PRP Consulting Team on Mar 20, 2024 2:15:49 PM

On March 13, 2024, the European Parliament approved the Artificial Intelligence Act (“AIA”), which represents the first comprehensive legal framework...

FDA Releases Quality Management System Regulation (QMSR) Final Rule

by PRP Consulting Team on Feb 22, 2024 12:23:15 PM

On January 31, 2024, the FDA issued its highly-anticipated Quality Management System Regulation (“QMSR”) Final Rule which amends current good...

Navigating FDA Regulatory Compliance for Medical Device Manufacturers

by PRP Consulting Team on Feb 8, 2024 7:57:55 PM

Discover the essential steps for medical device manufacturers to ensure FDA regulatory compliance and quality standards.

What are the FDA's Plans for 2024?

by PRP Consulting Team on Jan 17, 2024 11:00:00 AM

Quality and Regulatory Compliance within the medical device industry has become increasingly complex. FDA, as well as the various international...

New FDA Guidance for CM&S in Medical Device Submissions

by PRP Consulting Team on Nov 27, 2023 6:47:02 PM

On November 17, 2023, FDA published a new guidance document titled “Assessing the Credibility of Computational Modeling and Simulation in Medical...