Edward Panek | SpeakerHub

Personal Details

Bio

Quality and Regulatory Professional

FDA 510(k) Processes

ISO 13485

MDD/MDR

ISO 13485:2016 Certified Lead Auditor

GDPR

Eudamed

ISO 13485, 9001, IEC 80601-2-56

University Research to Industry Translation

After work hobbies include Chess and Neural Networks

Current position (1)

VP, Quality and Regulatory

Blue Spark Technologies

Degrees (1)

Electrical Engineering

Cleveland State University

2001 to 2006

Presentations (1)

ISO 13485 and Medical Device Requirements

An introduction to the application of ISO 13485 and Medical Devices

Past talks (2)

AI DeNovo Process

ASQ Boulder Colorado

Colorado

March 28, 2024

AI and ISO 13485

ASQ Metrology

Canton Ohio

October 20, 2023

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ISO 13485 FDA Artificial Inteligence