PRRC (Person Responsible for Regulatory Compliance)

• Manage Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities, including the development and maintenance of Plans and Reports.

• Maintain and update the Risk Management file, Usability Engineering file, and Biological Safety Evaluation.

• Verify content of Instructions for Use (IFU) to ensure compliance with MDR requirements.

• Coordinate and manage regulatory updates and potential changes to SOPs.

• Serve as lead auditor for internal audits, including the preparation and execution of internal audit reports.

• Provide assistance with NB (Notified Body) auditors’ queries and non-conformities during external audits.

• Ensure timely completion of annual PSUR (Periodic Safety Update Report) and PMCFR (Post-Market Clinical Follow-up Report) for all certified devices.

Annual Work Cycle:

• JAN: Manage PSUR and PMCFR reports.

• JUN: Lead internal audit and update regulatory SOPs.

• AUG: Oversee internal audit review during management review meeting.

• DEC: Manage external audit and address queries and NCs from NB auditors.

Devices Managed:

• 2 x Class IIa (MDR) – Well-Established Technology (WET)

• 2 x Class IIb (MDR) – WET

• 1 x Class IIb (MDR) – New device