Ronald Boumans, The Netherlands

Ronald’s work currently focusses on Clinical Evaluation Reports for high risk devices, but he also helps manufacturers with strategic decisions. He has a wide range of experience in borderline cases, where the product status is not immediately clear or where the risk class is an issue. He is also involved in market surveillance cases, where competent authorities need to be informed adequately. Within Emergo he concentrates on the transition from the Directives to the Regulations. This has also made him member of the MDR Eudamed Steering Committee and five of the seven MDR Eudamed Working Groups. He started working for Emergo in 2013. 

Before working for Emergo Ronald was a Senior Inspector at the IGZ, the competent authority for medical device for The Netherlands. As an inspector he has been involved in routine inspections of manufacturers of medical devices and IVD’s. He has worked on many market surveillance cases and on projects in which technical documentation of a cohort of manufacturers was linked to actual market experience in hospitals or other environments. He has represented The Netherlands in several working groups of the European Commission, like the MDEG on Borderline and Classification, the COEN working group and Eudamed. He has worked for the IGZ for more than 11 years.

Ronald compares Regulatory work with flying a plane: a good pilot can land his plane in a storm; an excellent pilot does not end up in bad weather. This summarizes well how he likes to navigate on behalf of the clients he works with.