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About me

I'm an engineer who connects two worlds that rarely talk to each other: regulatory affairs for medical devices and artificial intelligence.

My path here wasn't a straight line. Eight years of active service in the German armed forces, last as a captain, with a lot of organisation, training and IT projects, and a reservist ever since. Then a degree in medical engineering. Since then I've worked on implants such as stents and eye implants, as project lead, developer, inventor and regulatory expert. Today I use AI to build regulatory tools, learning games and commercials.

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Portrait of Michael Engel

Career

  1. since 2025

    Aesculap AG (B. Braun), Tuttlingen

    Regulatory affairs manager for implants, plus an "AI enabling" project for regulatory processes.

  2. 2021–2024

    ewimed GmbH, Hechingen

    Inventor, R&D engineer, project lead and product manager for class IIb and III stents, as well as regulatory and UDI expert.

  3. 2020–2021

    OSYPKA AG, Rheinfelden

    Technical project lead for the design transfer of eye implants into manufacturing.

  4. 2019–2020

    Getinge – Maquet Cardiopulmonary, Bodelshausen

    Project engineer (via Entourage).

  5. 8 years active

    German armed forces

    Officer, last rank captain: team lead for organisation and training, IT projects such as the HERKULES roll-out, deputy company commander. Reservist since.

Education

Why AI + RA

Why do regulation and engineering talk to each other so rarely? That question has stayed with me ever since I moved from the operating theatre into implant development. I’m curious, I’d rather try a new tool myself than read about it, and I like it when the text of a standard turns into something that helps in daily work. Right now, AI is the most exciting tool I know for that.

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