Ronald Boumans Email & Phone Number

The role of the PRRC is uncharted territory for the medtech field. The PRRC Academy develops a range of courses for PRRCs, online and in-person, to help this profession develop into a profession that is seen as an added value.

Munich, Bavaria, De

AR2-C2 stands for Authorized Representation Services 2.0 and Clinical Strategy Consulting Services 2.0. If a startup wants to be acquired by another company, it must provide clear evidence that its devices have potential in the global market. By complying with the strictest global requirements, being certified by one of the strictest notified bodies, and selling devices on one of the toughest markets in Europe, they are able to show convincing proof of concept. A team of experts helps them take all these steps, efficiently and effectively.

Oxford, Gb

Austin, Tx, Us

Austin, Tx, Us

Emergo's lead consultant regarding the introduction of the new Regulations for Medical Devices and IVDs (MDR and IVDR).Spearheading the transition to the new legislation for Emergo's clients as well as Emergo itself. Redefining the role as authorized representative as well as the role of consulting organization.Emergo's World-wide expert on borderline and classification question for European medical devices and IVD's.Board member of the European Association of Authorised Representatives (EAAR) and representing EAAR in the European Commission Working Groups for IMDRF, UDI and EUDAMED. Full member of the EUDAMED Steering Committee.For clients of Emergo: - drafting Clinical Evaluation Reports.- assisting in borderline questions regarding the definition of medical devices and classification of devices.- Technical File compilation, including Risk Analysis and Clinical Evaluations.- assisting with complicated incidents with medical devices in Europe.- on-site training MDR- assisting in planning the transition to the MDR/IVDR for SME's as well as large corporations- assisting in setting up the clinical evaluation procedure for medical devices under the MDR- assisting in setting up the performance evaluation procedure for IVD's under the IVDRManagement Representative for the quality system for the European offices.

Utrecht, Noord-Holland, Nl

As senior inspector I have been responsible for product safety of medical devices in The Netherlands. I have supervised manufacturers, authorised representatives and distributors nation wide. I have had contact with many of them over the recent years, and worked together with them to safeguard product safety. Once or twice a year there were cases that involved close contacts with politics and press.For the Inspection Academy I have been working as a teacher to introduce new inspectors of several Dutch inspectorates how to analyse incidents and how to behave during complicated inspections. I started with this work in 2006 and kept doing this until I left the IGZ in 2013.I was the project leader in a project to develop a risk model for supervision on manufacturers and distributors of medical devices.Apart from this work I also participated in three working groups of the European Commision:- Medical Expert Group on Bordeline & Classification, on the definition of medical devices and classification in risk categories;- Compliance and Enforcement Working Group, regarding market surveillance on a European level. This included interpretation of legislation as well as case studies regarding possible non compliances;- Eudamed working group, on the European Databank on Medical Devices. This working group assists the Commission with the development of the database on medical devices, economic operators, clinical evaluations, evaluations and incidents.

2595 Da The Hague, Nl

As senior project manager I acquired new projects and took care of planning and management of them. Most of these projects involved 'sitting and reclining'. This involved not only professional or consumer products, but also pressure ulcers. Interesting results have been the 'show room experience' by consumers when selecting a mattress in a shop on the one hand, and a conceptual model on causality of pressure ulcers.