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Software Validation and Re-validation Procedure - ISO 13485

Software Validation and Re-validation Procedure - ISO 13485

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ISO 13485 2016 + A11 2021 

QMS.4.1.6 - QP - Software Validation and Re-validation Procedure Template

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 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, then be modified to suit your company branding/marketing requirements.

 Frequently asked questions

What is Software Validation & Revalidation?

  • Software validation checks that the software product satisfies or fits its intended use and that it meets the requirements of the end-users.
  • Software validation and revalidation provides a tool for ensuring any calculations performed via software are producing consistent, accurate and reliable results. This is integral if you have modified software in any way or use such calculations for product validation, QC checks, equipment calibration etc.

Which clause within the ISO 13485 standard will this template help our company comply to?

  • The software acceptance testing template will aid your compliance with Clause 4.1.6 which states; the company should document procedures and records for the validation of computer software used within the QMS. Software should be validated before its first use, in addition, software revalidation is required if any further changes are made.

Do we require any supporting documents?

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

Quality Management Support:

If you are looking for support with your QMS then Patient Guards consultancy services could be a cost effective solution for your organisation.

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