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.

While working on a broad range of solutions from disease detection to electronic health records, I also learned what is (not yet) possible in the German healthcare market. Trying a different approach to change the status quo, I joined a Berlin-based startup soon after.

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.

Besides my company internal work, I stayed interested in the regulators’ perspective and joined working groups of the German Institute for Standardization (DIN) and WHO/ITU (AI4H initiative).

Like Oliver, I am not overly excited about regulatory consulting work but passionate about healthcare innovation. I trust that through sharing knowledge and open collaboration, we can help to bring additional clinical value to the market.

Let's talk?

No Cookie For You Privacy Policy Imprint
No QMS on this planet will save you from creating crappy software.