Affordable high end consulting

Your regulatory team is good; you see documentation being updated at regular intervals. However, sometimes there are these questions about the best interpretation of a specific article, or about interactions with the authorities where there is a lack of routine. At management level you may want to have a more strategic discussion, using decades of … Read more

Outsourcing PRRC

The new Regulations have introduced the role of the Person Responsible for Regulatory Compliance (PRRC). Manufacturers that want to rely on CE marking, manufacturers of custom made devices and authorized representatives must appoint a PRRC. For smaller companies and authorized representatives this can be outsourced. Boumans Regulatory Consulting can execute the role of the PRRC … Read more

Borderline and classification support

The first document a notified body will assess when they receive the technical documentation from a manufacturer, is the justification for the status of a medical device or IVD and the risk class. That is the document that will create your very first impression. In case of borderline products or devices with a classification that … Read more

Notified body search and selection

Regulation (EU) 2023/607, ammending the MDR, allows more time for the notified bodies to certify their companies. However, manufacturer must have entered an application with a notified body by 26 May 2024 in order to keep the legacy status of their devices. For companies that are still looking for a notified body, it is the … Read more

Emergency assistance

Any company can suddenly be hit by a complex and high risk case. In such situations it is necessary to get a good understanding of the underlying problem and of the expectations by the authorities and notified body, and also to ensure proper communication with all stakeholders, including the press. Leaning on in person experience … Read more

EUDAMED and UDI

EUDAMED is the IT system established by Regulation (EU) 2017/74) on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices and developed by the European Commission. A device identification system based on a unique device identifier (UDI) allows easier traceability of medical devices. Really, EUDAMED and UDI are in essence quite straightforward … Read more

Mergers & acquisitions support

That company you are about to buy, how state-of-the-art is their technology really? Or how ‘easy’ will it be to bring their device to the market? What are the consequences of a halted PMCF study? And if you are a start-up, how can you make sure potential buyers trust they understand your value? Is it … Read more