Knowledge Center
Explore our library of blogs, short videos, virtual event recordings and training topics
Recent Blogs
FDA Plans for Artificial Intelligence and Medical Products
AI has the potential to revolutionize healthcare, and the FDA wants to ensure that patient safety remains the top priority while fostering these cutting-edge advancements. That’s where their four areas of focus come in – collaboration, regulatory clarity, standards and best practices and research.
MoCRA’s Impact on Private Label Cosmetic Manufacturers: Navigating the New Era of Beauty Compliance
The Modernization of Cosmetics Regulation Act (MoCRA) is here, and it’s about to shake up the industry. As the FDA gears up to implement MoCRA by July 2024, it’s time for private label manufacturers to get their ducks in a row and embrace the new era of beauty compliance.
FDA Releases Drug Amount Report Final Guidance and Updated Deadlines
After an 829 day wait from the initial draft guidance, the FDA has issued the long-awaited Final Guidance on Reporting...
EC Proposal Updates on IVDR Transition & EUDAMED Rollout
Quick Insights from our experts on the EC Proposal concerning the IVDR transition and proposed MDR/IVDR amendment, possibly affecting the EUDAMED rollout. These are short segments created from our latest presentation, prepared exclusively for UDI customers.
Expert Insights on the EU Proposed Legislation EUDAMED Rollout
On January 23, 2024, the European Commission proposed a legislative amendment to address two major issues in the EU Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).
EUDAMED UDI Regulations: Best Practices for the New Year
Start the year with clean data and a firm understanding of what you must do for EUDAMED UDI compliance in 2024. UDI compliance readiness can be confusing. To help, we’ve gathered top tips from expert Gary Saner regarding upcoming milestones in the EUDAMED roadmap.