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    Vigilance System Procedure & Templates

    We have developed customizable MDR compliant Medical Device Vigilance System Procedure and Report templates in-line with EN ISO 13485:2016, Section 8.2.3 and MEDDEV 2.12-1 rev 6 guideline.


    During compilations of Medical Device CE Marking Technical File or part of stringent EN ISO 13485:2016 Implementation Vigilance Control System Procedure and Report Templates must be purchased, customized and easily implemented.

    Vigilance System Procedure

    Vigilance System Procedure : 200 USD

    Procedure ID : I3C-VSP-01

    Vigilance System Forms / Templates

    Urgent Field Safety Notice : 50 USD

    Template ID: I3C-TEM-VSP-01

    Manufacturer Incident Report : 50 USD

    Template ID: I3C-TEM-VSP-02

    Field Safety Corrective Action Report : 50 USD

    Template ID: I3C-TEM-VSP-03

    Manufacturer Periodic Summary Report : 50 USD

    Template ID: I3C-TEM-VSP-04

    Manufacturer Trend Report : 50 USD

    Template ID: I3C-TEM-VSP-05

    Advisory / Recall Register : 10 USD

    Template ID: I3C-TEM-VSP-06



    On receipt of payment confirmation, we will send a download link 2-6 hours. The link will be active for six months and in case of any revisions, it will get auto-updated.


    In case of any delay in receiving the link, please write to with details. We will make sure you will get it.

    PMCF Plan Template