Boumans Regulatory Consulting – More than 30 years of experience in compliance cases

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Boumans Regulatory Consulting wants to share more than 30 years of in depth experience in complex compliance cases.

With this support, companies can feel confident when making medical devices available on European markets.

A good pilot can land a plane in a storm ...

an excellent pilot knows how to avoid bad weather.

In the spotlight

Did you apply an adequate strategy to your Basic UDI?

The Basic UDI-DI provides the basis to your regulatory approach. If done well, it can drive the structure of the technical documentation and registrations in EUDAMED. Find out what such strategy should look like and how I can help.

Ronald Boumans helps organizations 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.

New in the expert center

Regulation (EU) 2023/607 MDR transitional arrangements for Class III and Class IIb, implantable devices

March 24, 2023

Regulation 2023/607 MDR transitional arrangements for Class IIa and Class IIb, non-implantable devices

March 21, 2023

MDR Article 120 and 122 consolidated

March 19, 2023

PRRC Academy

New trainings curriculum for 2023

PRRC online starter training

Regulatory skills training

Our expert services

Affordable high end consulting

Outsourcing PRRC

Borderline and classification support

Notified body search and selection

Emergency assistance

EUDAMED and UDI

Mergers & acquisitions support

Stadserf 114, 3112 DX Schiedam NL
+31 6 3928 0403
ronald@boumansconsulting.com
LinkedIn

Chamber of Commerce 86140671
VAT-id NL 8638 7506 3B01
IBAN NL11 ABNA 0111 5043 84
Swift code ABNA NL 2A

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Jannie de Groot Grafische vormgeving

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For PRRCs that want additional personal training, there is the option of booking this together with your training. For most PRRCs 2-5 hours will be adequate.

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