PMS & Vigilance System (PMS, FSCA, FSN)

Who This Kit Is For

RA/QA leaders and PMS managers who must implement a full post-market surveillance, FSCA and FSN system integrated with risk and CAPA.

The Compliance Problem It Solves

• Piecemeal PMS activities with no central plan or documented processes.
• Unclear criteria and workflows for FSCA, FSN and regulatory reporting.
• PMS outputs not tied systematically to Risk Management Files and CAPA records.

What You Get In This Kit

• PMS SOP and PMS plan templates covering data sources, analysis and reporting cycles.
• FSCA and FSN SOPs with structured decision trees, forms and templates.
• PMS report and trend analysis templates linking to risk and CAPA.

How This Kit Reduces Your Audit Risk

• Creates an integrated PMS and vigilance framework aligned with ISO 13485, MDR/IVDR and local vigilance rules.
• Provides clear documentation and decision-making evidence for FSCA and FSN activities.
• Demonstrates that PMS outputs are actively used to update risk assessments and drive CAPA.

How To Implement It (Step-by-Step)

1. Download and adapt the PMS, FSCA and FSN SOPs and templates to your regulatory jurisdictions.
2. Identify all PMS data sources and define data collection and review frequencies.
3. Implement decision criteria for FSCA/FSN and train relevant teams.
4. Use PMS reports and FSCA/FSN outputs as routine inputs into risk management and management review.

Technical & Regulatory Alignment

• Built for: ISO 13485:2016 clause 8; EU MDR/IVDR PMS and vigilance; local FSCA/FSN expectations.
• Typical use: systemic PMS system implementation and maintenance.
• Document type: PMS and vigilance system (SOPs and templates).