Post-Market Surveillance — Process Package (ISO 13485)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Process Package
Complete PMS system covering EU MDR Art. 83-86 + Annex III, MDCG 2022-21, MDCG 2020-7/8 (PMCF), ISO 13485 §8.2.1, ISO 14971 §10. Multi-class scaling (Class I = PMS Report; IIa/IIb/III = PSUR per F-ISO-11.1).
What’s included:
- SOP-ISO-28 Post-Market Surveillance — proactive + reactive PMS, data sources, analysis, action triggers, integration with Risk Management and Clinical Evaluation.
- F-ISO-28.1 PMS Plan (Word) — per-device family plan: Introduction, Scope, References, Description, Objectives (8 per Art. 84), Responsibilities, 7 Data Inputs (Sales, Feedback/Complaints, FSCAs, Audits, Literature, Public Data, Registries), Data Collection Methods, Statistical Analysis, Threshold Values, PMCF, Linked Processes, Reporting.
- F-ISO-28.2 PMS Report (Class I) (Word) — for Class I devices only (Class IIa/IIb/III use F-ISO-11.1 PSUR).
Why this package: PMS is mandatory for all CE-marked devices. This package gives you scalable PMS infrastructure (Class I report + PSUR linkage for higher classes).
Format: Microsoft Word (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase
€69.00
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Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.