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
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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
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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...
EU MDR – How It Impacts Post-Market Surveillance
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Stefanie Wichansky on Feb 21, 2024 5:39:21 PM
Navigating FDA Regulatory Compliance for Medical Device Manufacturers
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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?
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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
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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...
