FDA’s New QMS Guidance: What It Means for Premarket Submissions — and How to Stay Ahead of It December 4, 2025 Keep Reading
A Milestone Moment for Appraise-HRI — Now Published in The New England Journal of Medicine October 16, 2025 Keep Reading
Navigating Cybersecurity and Software Testing Requirements for Regulatory Submissions in the U.S., EU, Canada, and the UK August 13, 2025 Keep Reading
FDA Releases Updated Small Business Qualification Guidance for Medical Device User Fees (MDUFA) August 8, 2025 Keep Reading
