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Requirements for Servicing Activities Procedure - ISO 13485

Requirements for Servicing Activities Procedure - ISO 13485

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ISO 13485:2016 + A11 2021 

QMS.7.5.4 - QP - Requirements for Servicing Activities

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.

How will this template help my organisation?

  • ISO 13485 requires that if servicing of the medical device is a specified requirement, your organisation shall document servicing procedures, reference materials, and reference measurements, as necessary, for performing servicing activities and verifying that product requirements are met.
  • This template will provide you with a framework to establish the requirements needed for servicing of your medical device products.
  • If your medical devices do not require servicing, then this part of the standard is not applicable.

What are the requirements?

  • Requirements for Servicing Activities can be anything your medical device or customer would need to carry out servicing.
  • This could include:
    • whether or not the medical device needs to be returned for servicing or a site visit is required,
    • whether or not the medical device requires decontamination prior to servicing,
    • what work instructions/procedures are relevant to servicing.

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 qmsregs@patientguard.com.

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