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Mar 07, 2023

Medical Device Software Changes: Getting the RA and Dev Teams on the Same Page

Mar 02, 2023

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

QSIT Audit

Feb 20, 2023

Understanding What Happens During a Medical Device QMS Inspection

Feb 14, 2023

What Is Considered a Significant Change Under EU MDR Article 120(3) and MDCG 2020-3?

Feb 13, 2023

An Overview of Medical Device Periodic Safety Update Reports (PSUR) and Postmarket Surveillance Reports (PMSR) Under the EU MDR

Planning root cause analysis

Jan 29, 2023

Dig Deep and Do Medical Device Root Cause Analysis the Right Way​