Edward Panek

Edward Panek

About

Edward is a quality and regulatory professional with over 20 years of experience in medical device quality, including AI. He specializes in FDA 510(k) processes, ISO 13485, and MDD/MDR compliance, and is a certified ISO 13485 lead auditor.

Outside of work he enjoys chess and neural networks. Ask about FDA submissions, ISO 13485 audits, or quality systems for medical devices.

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