ISO Cloud Consulting
PMS & Vigilance System (PMS, FSCA & FSN)
PMS & Vigilance System (PMS, FSCA & FSN)
Post-market surveillance often becomes reactive, with complaint data, vigilance decisions, and field actions spread across disconnected logs and email threads. This system gives you a usable post-market structure for planning, trending, escalation, field actions, and regulatory response documentation. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.
What's included
- PMS Plan.docx
- PMS Report Template.docx
- Field Safety Corrective Action SOP.docx
- Field Safety Notice Template.docx
- FSCA Response Form Template.docx
- Incident Report Register.xlsx
- Complaint Trend Sheet.xlsx
- Signal Review Workbook.xlsx
- Implementation Guide.pdf
Best suited to: Quality manager, Regulatory affairs, Distributor, and Manufacturer.
Useful in audit situations where you need to:
- Show a structured post-market surveillance and vigilance process during ISO 13485 certification, surveillance, supplier, or internal audits.
- Support FDA inspections with controlled records, traceability, and process evidence related to post-market surveillance and vigilance.
- Support EU MDR technical documentation or quality-system reviews where post-market surveillance and vigilance records need to be complete, controlled, and consistent.
Use this system to move faster, create cleaner evidence, and reduce the time it takes to stand up or repair this part of your ISO 13485 framework.
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Why Medical Device Companies Use ISO Cloud Consulting Toolkits
Our toolkits are designed by regulatory professionals who work with:
• ISO 13485 certified manufacturers
• medical device startups
• EU MDR compliance projects
• FDA design control programs
Each toolkit contains practical templates used during real audits.
Built for Real Regulatory Audits
These templates are aligned with:
• ISO 13485:2016
• ISO 14971 risk management
• FDA design control expectations
• EU MDR QMS requirements
Auditors evaluate documented evidence, not theory.
These toolkits give you the exact records auditors expect to see.
Start Building Your Audit-Ready QMS Today
Download instantly and begin implementing your system immediately.