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.
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What's Inside
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of real FDA 483 observations
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FDA Inspection Readiness Checklist
27-point checklist based on real 483 observations
Quarterly Regulatory Updates
Free updates when FDA guidance changes
Implementation Quick-Start Guide
Step-by-step instructions to deploy templates in your QMS
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Benefits
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Is This For You?
This toolkit is designed for teams facing these challenges:
Who This Is For
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Frequently Asked Questions
What file formats are included?
All 7 templates are in Microsoft Word (.docx) format. The Trend Analysis Procedure includes an Excel companion with pre-built statistical control charts.
Which regulations does this cover?
EU MDR Articles 83-86 and Annex III (PMS), EU MDR Annex XIV Part B (PMCF), FDA 21 CFR Parts 803 and 806 (MDR reporting and corrections/removals), and ISO 13485:2016 Clause 8.2 feedback requirements.
Who is this for?
Companies selling in the EU under MDR (mandatory PMS system), FDA-regulated manufacturers required to submit MDRs, and any QA/RA professional responsible for post-market activities. Also essential for NB audit preparation.
How often is the PSUR required?
EU MDR Class III and implantable Class IIb: annually. Other Class IIb: every 2 years. Class I and IIa: PSUR not required, but PMS Plan and summary are. The template covers all classes.
What's the difference between a PMS Plan and a PMCF Plan?
The PMS Plan covers all post-market data sources (complaints, MDRs, literature, registries). The PMCF Plan is specifically for planned clinical follow-up studies to fill ongoing clinical evidence gaps identified in the CER.
What are EU MDR vigilance reporting deadlines?
Serious incidents: 15 days (immediately life-threatening: 2 days, non-serious: 30 days). FSCAs: before implementation or immediately after if urgent. The Vigilance Reporting Procedure includes a timeline decision tree.
How does this integrate with our complaint handling system?
The PMS Plan includes complaint data as a primary input source. The Trend Analysis Procedure references complaint trending data. Templates include cross-reference fields to your complaint handling records.
Will I get updates when EU MDR PMS guidance is revised?
Yes — free updates by email. MDCG PMS guidance is actively evolving; we track changes and update templates accordingly.
What's your refund policy?
7-day Audit-Ready Guarantee. Full refund within 7 days — email support@regwatchdaily.com.
How does this compare to a consultant-built PMS system?
EU MDR PMS consulting engagements run $10,000-40,000+. These templates give your team the same framework Notified Bodies accept — implemented internally at a fraction of the cost.
What file format are the templates in?
All templates are provided in editable Microsoft Word (.docx) format. You can customize them to match your company's branding and specific requirements.
How quickly will I receive the files?
Instantly. After purchase, you'll receive an email with download links within 2-3 minutes. Check your spam folder if you don't see it.
Can I use these for multiple projects or clients?
Yes. Your purchase includes a company-wide license. Use the templates across all your projects and devices within your organization.
Do these templates get updated when regulations change?
Yes. You'll receive free updates via email whenever we update templates for new guidance or regulatory changes.
What if I need help customizing the templates?
Email us at support@regwatchdaily.com. We typically respond within 24 hours with guidance on customization.
Is there a money-back guarantee?
Yes — the Audit-Ready Guarantee. If you're not satisfied within 7 days, email us for a full refund. No questions asked.
Ready to Get Audit-Ready?
7-Day Iron-Clad Guarantee
Download everything. Review every template. If it doesn't save you at least 40 hours of documentation work, email us for a full refund. No questions. No hassle.
Every week without proper documentation is another week of audit exposure.