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FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Need to Know
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ISO 13485:2016 and ISO 9001:2015: Are They Aligned?
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Medical Device QMS 101: What It Is, Where It’s Required, and Key Regulations to Know
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FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works.
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How to Conduct an Internal Audit Opening Meeting: Tips from Training 130,000+ Medical Device Auditors
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Listen and Learn: Develop These Soft Skills and Become a Better Medical Device Auditor
