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The Post Market Surveillance Procedure governs all post market surveillance activities and provides instruction on: Post Market Surveillance Plans and Reports; and Post Market Clinical Follow-Up (PMCF) requirements including easy to follow templates.
- MEDDEV 2.12/1 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Instant Download Digital Content
Post Market Surveillance ProcedureThe Post Market Surveillance Procedure is developed in accordance with MEDDEV 2.12/1 and ISO 13485:2016 requirements.
Post Market Surveillance SystemThe Post Market Surveillance Procedure helps plan, establish, document, implement and update post-market surveillance in a manner that is proportionate to the risk class and appropriate for the type of device.
The Post Market Surveillance Procedure governs all post market surveillance activities and provides instruction on: Post Market Surveillance Plan and Report (Includes Sample Plan); and Post Market Clinical Follow-Up (PMCF) requirements. Post Market Surveillance Procedure ComplianceThe Post Market Surveillance Procedure complies with MEDDEV 2.12/1, European Medical Device Regulation MDR (EU) 2017/745, ISO 13485:2016 and FDA QSR.
For more information about our Post Market Surveillance Procedure contact us [email protected] RELATED LINKS |
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