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Mar 01, 2024

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

Jan 10, 2024

ISO 13485:2016 and ISO 9001:2015: Are They Aligned?

Nov 30, 2023

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

Safety and Performance-Based Pathway Simplifies

Sep 10, 2023

FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works.

Mar 02, 2023

How to Conduct an Internal Audit Opening Meeting: Tips from Training 130,000+ Medical Device Auditors

business women auditing employee

Jun 09, 2022

Listen and Learn: Develop These Soft Skills and Become a Better Medical Device Auditor​