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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

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

Over 1,000 notified body applications per month. Will your device be among them?

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

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

PRRC Academy

Masterclass PRRC

New trainings curriculum for 2024

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

Boumans Regulatory Consulting BV

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