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Mar 31, 2025

Less Than A Year to Go! FDA’s New Quality Management System Regulation (QMSR) Is Getting Closer

Jun 27, 2024

FDA QSR vs. QMSR: What Medical Device Manufacturers Need to Know

Dec 11, 2023

Overview of FDA Advertising and Promotion Regulations for Medical Devices

Nov 30, 2023

Medical Device QMS 101: What It Is, Where It’s Required, and Key Regulations to Know

Nov 01, 2023

A Guide to FDA Clinical Decision Support (CDS) Software Approval

MDSAP Planning

Oct 16, 2023

The FDA 510(k) Process: Setting the Stage for a Successful Submission and Faster Approval