Post-market surveillance, PMCF, and vigilance systems designed to stay current after certification — plus the internal audit and management review structures that keep them that way.
What this covers
Post-market surveillance (PMS) system design and plan development
PMCF planning, execution structure, and reporting
Vigilance and trend analysis integration into the QMS
Internal audit framework design and audit program structure
Management review and governance structure supporting ongoing compliance
Regulatory gap assessments ahead of renewals or market expansion
When this is typically needed
Building a PMS system for first-time EU MDR compliance
Structuring PMCF activities for an active clinical evidence gap
Internal audit or management review processes are informal or inconsistent
Preparing for periodic safety update reports or market expansion