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Check List for ISO 13485:2016+A11:2021

Check List for ISO 13485:2016+A11:2021

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ISO 13485:2016+A11:2023 - Check List

Our 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. For updates on Regulatory and Quality Assurance news visit Patient Guards blogs.

Why do I need an ISO 13485 checklist?

This comprehensive medical device  ISO 13485:2016+A11:2021 Quality Management System checklist allows you to identify which clauses are applicable to your medical device(s) and input the reasonings behind your decision. It also allows you to input which evidences you have to prove that each clause has been fulfilled. 

This template should give you a clear overarching view to quicky identify that you are meeting the requirements needed for your medical device Quality Management System. This helps you to ensure that you meet all the applicable clauses of the standard, which is useful when being audited by a Notified Body or Certification body. 

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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