How to become the best PRRC ever? [Ronald Boumans]
Becoming the best PRRC ever is something that all PRRC should go for. The PRRC role is really important to avoid some situations that happened like the PIP scandal or recently the Philips issue.
PRRC means Person Responsible for Regulatory Compliance and this is a mandatory role within the Medical Device industry. So if you still have no PRRC within your company then this can be a problem. So learn more about it.
Ronald Boumans will help us understand what should we do to become the best PRRC ever.
Who is Ronald Boumans?
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 multiple 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.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video
- Boumans Regulatory Consulting website: https://boumansconsulting.com/
- Ronald Boumans LinkedIn: https://www.linkedin.com/in/ronald-boumans-34790055/
- Team-PRRC Annual Meeting: https://www.team-prrc.eu/collect/description/254458-u-team-prrc-annual-summit-event-in-brussels-in-3-4-november-2022-for-public
- Team-PRRC website: https://www.team-prrc.eu/page/1111392-presentation
- PRRC Video LinkedIn Live: https://www.youtube.com/watch?v=RHRI9UjEdjs