The PRRC, or Person Responsible for Regulatory Compliance, is a new role introduced by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The PRRC is responsible for ensuring that a medical device manufacturer complies with all applicable EU regulations.
At Asphalion we can help you with your PRRC needs. We have a team of experienced regulatory experts who can provide you with the support you need to comply with the EU MDR and IVDR in all aspects of the PRRC process: from qualification and appointment to day-to-day support. We can also help you with other regulatory affairs matters, such as product registration, documentation preparation, and audit support.
Have a look at everything to take into account regarding the role of PRRC here: Asphalion PRRC Services
To learn more about Asphalion PRRC services, please contact us at: medtech@asphalion.com
Or schedule a free 30-minutes meeting here: https://bit.ly/3NwVsNR
