Ronald Boumans has seen the medical devices field from almost every corner thinkable (R&D, distribution, research, certification, standard development, market surveillance, policy making, stakeholders representation and consulting), so he can approach most challenges from mulitple angles.
This helps the organizations he works with to adapt their approach to their challenges and keep full control over their processes. The ability of thinking out of the box is a precious added value in the field of regulatory compliance.
Graduated as an engineer in industrial design at the Technical University of Delft in 1986, Ronald started his career in R&D for medical devices (including package design). He then moved to importing and distributing devices in The Netherlands, followed by quality research and rearch into the relation between medical devices and quality of life.
This brought him to work for the Dutch competent authority as a senior inspector for medical technology. In 2013 he became a senior regulatory consultant at Emergo. In 2022 he started his own consulting company.
Ronald Boumans brings with him 30+ years of experience in the medical device sector. He began in industry as a product designer of medical devices; started a company importing medical devices into The Netherlands from Asia; participated in research into quality of patients’ lives in relation to the use of medical devices; worked 10+ years as an Inspector for the Dutch Healthcare Inspectorate, the Competent Authority for The Netherlands; and worked for nine years as a senior regulatory consultant for Emergo Europe Consulting B.V..
As Senior Inspector, Ronald led a team responsible for manufacturers, importers and distributors of medical devices and IVD’s in the southern half of the country. He was further an incident analyst, a root cause analyst specialist, a trainer at the Dutch Inspection Academy, and represented The Netherlands in several working groups at the European Commission, such as the Compliance and Enforcement (COEN) group and the Medical Device Expert Group (MDEG) for borderline devices and classification. Ronald was also involved in the first impact assessments of the MDR/IVDR.
For Emergo by UL (2013-2019) Ronald has worked on 200+ projects, including Technical Files, Clinical Evaluation Reports, helping “orphaned” manufacturers maintain CE marking after their Notified Bodies left the market and gap assessments between the MDD and MDR. He also developed several MDR related trainings, which he provides globally. In uncertain situations, like Brexit or the Swiss relations to the EU, he used his extensive network to help Emergo and its clients navigate unclear waters.
On behalf of Emergo by UL, he sat on the Executive Board of the European Association of Authorized Representatives (EAAR). Ronald represented the EAAR in several groups at the European Commission, including the new EUDAMED Steering Committee and several of its working groups, such as post-market surveillance, vigilance, data exchange, as well as the MDCG working group on UDI. He also took part in stakeholders meetings with the European Commission. He also was board member on behalf of Emergo UK in the UK Responsible Person Association (UKRPA) where he frequently took part in meetings with the MHRA.
He has developed a deep understanding of the role of the Person Responsible for Regulatory Compliance (PRRC). He is also board member of TEAM-PRRC, where he helps shaping this new profession. He is involved in further developing the industry level of understanding of this role via his network and by developing guidance and training.
Sampling of experience, not comprehensive
Clinical Evaluation Report compilation for a wide range of devices, including but not limited to:
A wide range of borderline and classification questions, including but not limited to:
Urgent ad hoc projects, including but not limited to:
EU MDR transition gap analysis and gap closure
I highly recommend Ronald’s PRRC training series. I joined the April 2023 session and we had a blast discussing real life cases and dilemma’s we encounter navigating the complexity of
I was looking for PRRC training for the SOPHiA Genetics team that would be practical and provide more insight than repeating what I can read. I was searching for someone
Active Implants has been working with Ronald for several years. During that period he has helped us determine strategies to effectively navigate through evolving regulatory compliance environment and through regulatory
I’ve known Ronald for many years and know him to be a true expert in the field of QA/RA! He is a frequent contributor to the Elemed MDR/IVDR forum – a
Thank you for a very helpfull piece of advise, when you suggested that I should write a rationale for me being appointed as PRRC in my company. Only a few
Ronald has unique ways of approaching a problem. He always looks at it from multiple perspectives and is great at seeing what could be lurking around the corner, or which
Boumans Regulatory Consulting BV
