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Vigilance System Procedure

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 guidelines.


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.



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

Vigilance System Procedure

Type : Procedure
Title : Vigilance System Procedure
Document ID : I3C-VSP-01
Price : $100
Number of Downloads (until 10/2022) : 400

40 reviews

Vigilance System Forms / Templates

Type : Templates
Title : Urgent Field Safety Notice
Document ID : I3C-TEM-VSP-01
Price : $50
Number of Downloads (until 10/2022) : 20

05 reviews

Type : Templates
Title : Manufacturer Incident Report
Document ID : I3C-TEM-VSP-02
Price : $50
Number of Downloads (until 10/2022) : 30

10 reviews

Type : Templates
Title : Field Safety Corrective Action Report
Document ID : I3C-TEM-VSP-03
Price : $50
Number of Downloads (until 10/2022) : 120

40 reviews

Type : Templates
Title : Manufacturer Periodic Summary Report
Document ID : I3C-TEM-VSP-04
Price : $50
Number of Downloads (until 10/2022) : 10

05 reviews

Type : Templates
Title : Manufacturer Trend Report
Document ID : I3C-TEM-VSP-05
Price : $50
Number of Downloads (until 10/2022) : 60

30 reviews

Are you looking to buy? Please read and agree to the terms and conditions before proceeding with the purchase.



We have been in the regulatory consulting business since 1999. After two decades, we have grown to be one of the largest groups, with offices in more than six countries. More than 2000 companies are connected to us in some way and will always be with us in the coming years.

Our service quality is primarily determined by the highly qualified professionals who work with us. We value our customers and respond to them when they have a need.



The files you purchased are not downloaded automatically. After obtaining payment confirmation, you will receive an email within 1-6 hours. (Sundays are days off.)


Our technical experts create the softcopy procedures, templates, and checklists for sale after interpreting and debating guidelines. The briefings or explanations given in each section do not constitute an official or signed contract, and no grievances will be considered. Buyers should keep in mind that the writers are human beings, and there might be a few flaws as interpreted by regulatory authorities or other professional experts in this area.

Refund Policy

We will NOT issue a refund once the softcopy document has been submitted.



Softcopy procedures, forms, and checklists for sale must be updated and filled out according to the scope of the product. We cannot guarantee that simple forms will be accepted by the NB or FDA, but properly filled forms based on our advice will have a better chance of being accepted.


Along with the purchased softcopy document, a copy of the invoice will be attached. PayPal will produce the invoice. There will be no different invoice.

Contact us

Reach us via Global toll free number 1800 94 91 2881
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If you do not receive the link via email within a reasonable amount of time, please register a complaint. We’ll make certain you get it.

I have read and agreed to the terms of purchase listed above.