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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.

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