Ronald Boumans

EAAR Member of the Board, Senior Global Regulatory Consultant, Emergo, The Netherlands

Ronald is currently busy assisting Emergo clients to prepare for the MDR. He assists in developing and implementing regulatory strategies, corporate policies and complex change processes related to MDR compliance. He is also helps companies finding a suitable notified body, sometimes with very short timelines. Over the last few years he has been member of the Eudamed Steering Committee and several of the Eudamed working groups. He expects the coming year Eudamed implementation will require a lot of his attention. 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.