Why the PRRC is so important for companies

The presence of a PRRC is not a mere administrative formality, but a cornerstone of regulatory governance.

This role helps ensure that every device placed on the market:

• is supported by complete, up-to-date technical documentation;
• complies with the General Safety and Performance Requirements (GSPR);
• is backed by adequate evidence of safety, clinical performance and technical performance;
• is subject to a structured post-market surveillance process (PMS, PMCF);
• is managed in a compliant manner throughout its entire life cycle.

The PRRC service provided by MediQuasar

MediQuasar offers companies a highly qualified PRRC, able to assume the role under Article 15 of the MDR/IVDR through a formalised and recognised appointment.

What we deliver as your external PRRC:

• Oversight of device compliance prior to placing on the market.
• Review of technical documentation, including updated technical files, clinical evaluations, risk analyses and GSPR matrices.
• Verification of PMS/PMCF activities, incident management and corrective actions.
• Ongoing compliance of the quality management system in line with ISO 13485 and MDR/IVDR requirements.
• Validation of internal regulatory processes, ensuring traceability, transparency and coherence across all company functions.
• Support in interactions with Notified Bodies and competent authorities, providing an authoritative technical and regulatory channel.

With an operational and independent approach, MediQuasar’s external PRRC integrates alongside—instead of replacing—internal teams, enabling genuine capability building and stable regulatory management over time.