QA/RA Management and PRRC

The EU Medical Device Regulation (MDR) introduced a new requirement/role: now, every manufacturer and EU authorised representative must have a PRRC (Person Responsible for Regulatory Compliance).

PRRCs must demonstrate adequate qualifications for this role.

The PRRC role can be outsourced to Eurofins Medical Device Consulting.

Medical device manufacturers can also rely on our QA/RA services for:

• Vigilance
• Re-certification
• General Safety and Performance Requirements (GSPR)
• Post-Marketing Surveillance (PMS)
• Post Market Clinical Follow-up (PMCF)