QA/RA Consulting, Auditing & Training


Let's get started

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 08, 2023

FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Need 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

Jun 28, 2023

Understanding the FDA De Novo Approval Process for Novel Medical Devices