Person Responsible for Regulatory Compliance

Manufacturers are either transitioning to or entering the market under the new medical device regulation. A new requirement of the MDR and of the IVDR, is to have always at their disposal, a PRRC. We fulfill this function for small medical device companies (less than 50 employees).

The PRRC function has specific requirements, so small companies may have difficulties employing someone who has the educational background and/or the experience required by the medical devices regulations. As such, the regulation allows for smaller companies to hire external parties to fulfill the function of PRRC.