Free Course: Quality Management For Medical Devices (ISO 13485 QMS)
Sven Piechottka
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ISO 13485: Quality Management For Medical Devices
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Updated November 26, 2025
Introduction to our free course on quality management for medical devices in accordance with the ISO 13485! You'll learn how to set up your quality management system (QMS) and we'll show you how to fill out our free templates along the way.
If you haven't yet, check out Formwork, the most affordable eQMS software for medical devices:
https://openregulatory.com/
If you haven't yet, check out Formwork, the most affordable eQMS software for medical devices:
https://openregulatory.com/
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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.
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.
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