Oliver Thilmann works with manufacturers of complex active medical devices to translate regulatory requirements into practical ways of working. With more than 20 years in medical technology, the last six in regulatory consulting, he knows both what a notified body expects and what it costs those who build products and run quality systems.

A physicist by training, Oliver started at Siemens Healthcare developing algorithms for particle therapy planning, then build and lead the development and predevelopment teams. At KUKA, he took this experience into medical robotics, leading system risk management and verification, and taking products through IEC 60601-1 testing and into production.

He contributes to standardization as co-author of IEC 80601-2-78 on rehabilitation robots and of IEC TR 60601-4-1 on degrees of autonomy and as a member of the DIN committee on artificial intelligence in medicine and healthcare.

His work covers regulatory strategy under MDR, technical documentation, and quality management systems to ISO 13485 that fit the product class and the size of the team. He supports development and certification projects, with particular expertise in integrating product, software and usability risk management. He conducts internal audits and takes on PRRC or interim quality management roles, or coaches the people in them.

Oliver works across Europe, remotely or on site as the project requires.