Document and Record Control For The ISO 13485
Sven Piechottka
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ISO 13485: Quality Management For Medical Devices
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Updated November 26, 2025
The ISO 13485 is the standard for quality management for medical devices. It has some very specific ideas on how you should manage your documents and records. We'll walk you through how to set that up in a compliant 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/
Keep watching
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Document and Record Control For Medical Device Quality Management Systems (ISO 13485 QMS)
Dr. Oliver Eidel
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almost 4 years ago
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ISO 13485 - Compliant Handling Of Records, Save Time Using OpenRegulatory Templates
Dr. Oliver Eidel
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Certification and Product Registration Process
Sven Piechottka
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7 months ago
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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