20+ year veteran in Medical Device Quality & Regulatory Affairs (ISO 13485 / FDA QSR).

After two decades of manually auditing Design History Files (DHFs) and fighting the same “Fatal 5” logic gaps, I decided to stop complaining and start coding.

I am now the founder of MedComplyAI, a free diagnostic tool designed to help consultants and QA teams “pre-audit” their Design Controls in under 60 seconds.

My mission is simple: To eliminate “Ambiguity” from requirements before the auditor ever arrives.

Always happy to connect with fellow auditors, consultants, and QMS nerds to swap war stories.