General information

Over the last years, a more stringent EU MDR-regulation is applicable for all medical devices to be placed on the EU market. That means that your new idea or device needs to meet high levels of safety and performance requirements. Can you still get to market in a timely manner? Is this “MDR” a burden? Or can you use it during your development process?

This workshop is organized for start-ups to develop, next to their business plan, also a regulatory strategy:  How to identify MDR requirements and integrate them in your User Requirements.

This session will be held by Mr. Robert van Boxtel, who has decades of experience in developing devices in the highly regulated Medical Device industry.

Speaker

Robert van Boxtel is Principal Consultant and management team member at MDProject in the Netherlands. For almost 15 years, he supports the medical device industry with QA and RA related consultancy, focusing on the EU and USA.
As a Board Member of the RAPS Netherlands Chapter he contributes to two RAPS conferences in the EU and the Medtech Summit in Europe.

Program

Partner information

MDProject

Lupinesingel 556, NL-2403 EB Alphen aan den Rijn
T: +31 (0)172 421 303
E: info@mdproject.nl