Template: List of Medical Device Consultants

Sven Piechottka ISO 13485 Templates Published July 27, 2022 Human Resources

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This is a free template, provided by OpenRegulatory.
If you are a user of Formwork, our eQMS software, you can save a lot of time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, then opening the relevant folder to find this template ready to load into Formwork.

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List of Medical Device Consultants

This template is only necessary for German medical device manufacturers as the role of a Medical Device
Consultant is specific to German Medical Device Law (§ 83 MPDG / § 31 MPG).

Full Name Role / Team / Position Medical Device Date of Last Training Proof of Training Comment
Jack Rack Business Development Manager (...) (...) <link training record> (...)

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license
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Please don't remove this notice even if you've modified contents of this template.

Sven Piechottka avatar

Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.