View the talks from the OpenRegulatory Conference 2021!

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.

Questions?

Regulatory compliance is not rocket science.

But finding a good consultant is.

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