Dr Jurjen Zoethout
Chief Operating Officer
Dr. Jurjen Zoethout has 15+ years of experience working in cross-functional projects in the fields of medical devices (Drug Coated Balloons, Drug-Eluting Stents) and mechatronic applications (Virtual Reality medical training simulators, automated manufacturing, mobile robotics). He has been responsible for international project management (EU, US, JP), defining, developing and implementing clinical trial (CIP, IB, CTA), regulatory (CE), QA (ISO 13485, 21 CFR Part 820) as well as for conducting M&A due diligence. Jurjen is ready to help clients to determine the most appropriate development and regulatory pathways to bring novel medical devices to global markets. He can also participate in design review and risk management activities, interfacing with Notified Bodies and Competent Authorities.