About Me
I am a medical technology and regulatory affairs professional with more than 14 years of experience delivering innovative and safety‑critical medical devices at Brainlab AG. My expertise spans the full lifecycle of complex medical products—from strategic planning and system design to implementation, verification, documentation, and regulatory submissions.
I specialize in applying and interpreting IEC 60601 standards, including both collateral (60601‑1‑X) and particular standards (60601‑2‑X), as well as functional safety documentation and CB Report preparation. My work supports successful MDR technical file audits and FDA 510(k) submissions, ensuring that products meet global safety and performance expectations.
Standards & Committee Work
I am actively involved in shaping international medical device standards through several key roles:
- IEC 60601 family — Contributing expert and co‑author in multiple working groups developing safety and performance standards for medical electrical equipment.
- IEC SAG Healthcare, Topic AI — Member of the Strategic Advisory Group focusing on artificial intelligence in healthcare.
- IEC SNAIG (Safety of Networked AI Groups) — Participant in activities addressing safety considerations for networked and AI‑enabled systems.
- CEN‑CENELEC TC 62 — Active member in the European technical committee for medical electrical equipment.
- Outgoing representative to JTC 21 — Representing TC 62 in the joint technical committee responsible for AI standardization across Europe.
Through these roles, I contribute to the development of future‑proof standards that support safe innovation in medical technology, AI‑enabled systems, and networked healthcare environments.
