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QA/RA Consulting, Auditing & Training

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Fixing Devices

Jan 11, 2024

How FDA Distinguishes Between Medical Device Servicing and Remanufacturing

FDA's Case for Quality

Jan 10, 2024

The US FDA Case for Quality (CfQ): What It Is and Why You Should Care

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

business women auditing employee

Jun 09, 2022

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

Jan 28, 2022

How to Prepare for and Conduct an ISO 13485 Internal QMS Audit