$247 — Standard Tier

Post-Market Surveillance Toolkit: PMS Plan, PMCF & PSUR Templates

Complete post-market surveillance toolkit with PMS plan, PMCF templates, PSUR guidance, complaint handling, and vigilance reporting procedures.

Get the Toolkit — $247

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What's Included

Post-Market Surveillance Plan Template
Post-Market Clinical Follow-up (PMCF) Plan Template
PMCF Evaluation Report Template
Periodic Safety Update Report (PSUR) Template
Trend Analysis Procedure
Field Safety Corrective Action (FSCA) Procedure
Vigilance Reporting Procedure

Benefits

EU MDR compliant PMS system
Proactive safety signal detection
PSUR structure that satisfies Notified Bodies
Clear vigilance reporting process

Is This For You?

This toolkit is designed for teams facing these challenges:

PMS is reactive instead of proactive
No formal PMCF process
PSUR requirements are confusing
Vigilance reporting deadlines missed

Who This Is For

Companies selling in EU under MDRRA/QA professionals responsible for PMSCompanies preparing for NB audits

Frequently Asked Questions

Is this required for FDA?

FDA has post-market requirements too, but EU MDR is more prescriptive. Templates work for both.

How often is PSUR required?

Depends on device class. Class III: annually. Class IIb implantables: annually. Others: as needed or every 2-5 years.

Related Toolkits

Complaint Handling

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FDA + EU MDR Dual Compliance

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Clinical Evaluation (CER)

$297

Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $247

7-day money-back guarantee