I’m an Experienced MedTech Leader offering services to bring your medical device concepts to market with the necessary urgency. I can help you with efficient development processes, quality and regulatory requirements and a pain-free route from idea to market approval.
Areas of expertise
Design control and technical documentation
ISO 13485 Quality Management Systems
Software development processes according to IEC 62304
Risk management according to ISO 14971
Technical File (EU) and 510(k) (US) submissions
Generation and protection of intellectual property
Outsourcing and transfer to manufacturing
Bio/ Achievements
Experience: Director R&D, Quality & Regulatory, achieved 510(k) clearances & MDR certificate
Doctorate Technical University Munich 2012 | Scientific publications cited 2500+ times
10 patent applications in the field of intraoperative fluorescence imaging