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Reporting to Regulatory Authorities Procedure - ISO 13485

Reporting to Regulatory Authorities Procedure - ISO 13485

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ISO 13485: 2016 +A11 2021 

QMS.8.2.3 - QP -  Reporting to Regulatory Authorities Vigilance (UK-EU) Procedure

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements.

What is Vigilance Reporting?

  • Vigilance Reporting is the process of assessing, investigating and reporting user complaints and incidences whereby patient injury, adverse health effects or death are brought about by the Medical Device misuse or malfunction.
  • The purpose of this procedure is:
    • To define the actions your organisation will take following a notification of an incident that is reportable to or by the Competent Authorities.
    • These actions must be in accordance with the applicable reporting responsibilities.
    • To define Vigilance and post-market surveillance for all products for which your organisation is the legal manufacturer.
  • An example of Vigilance Reporting is a Field Safety Corrective Action Notice (FSCA).

    If you would like further information on our wide range of templates or have any suggestions for improvements that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at

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