PMS-001
Post-Market Surveillance Procedure
Version
v1.0
Effective Date
May 8, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
Management Representative
Owner
Management Representative
ISO Clause
8.2.1, 8.2.3, 8.2.4, 8.2.5
Category
Post-Market Surveillance
Procedure for collecting, monitoring, analyzing, and acting upon post-market information, including complaint handling, vigilance reporting, trend analysis, PSURs, PMCF, and field safety corrective actions.
#pms#post-market#vigilance#complaints#fsca#eumdr#fda
Regulatory Standards
ISO 13485:2016EU MDR 2017/74521 CFR Part 80321 CFR Part 820
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 8, 2026 | Management Representative | Initial release |