Cybersecurity continues to evolve throughout all facets of the business world, and the medical device industry has taken notice. FDA has published...
PRP Consulting Team
Recent Posts
Artificial Intelligence Act - What You Need to Know
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
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
Discover the essential steps for medical device manufacturers to ensure FDA regulatory compliance and quality standards.
What are the FDA's Plans for 2024?
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
On November 17, 2023, FDA published a new guidance document titled “Assessing the Credibility of Computational Modeling and Simulation in Medical...
New FDA Guidance on the Q-Submission Process
The introduction of new and complex regulations, combined with the need to get safe and effective devices approved and into the market as quickly and...