Device History Record Procedure - ISO 13485

ISO 13485:2016 +A11 2021 

QMS.7.5.1 - QP - Device History Record

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 a Device History Record?

• A Device History Record (DHR) is a record that contains all documentation related to the manufacture and monitoring of the specified device.
• It must also demonstrate that the device has been manufactured in line with the specifications laid out in in any applicable product design document such as QMS.7.0.0 - QP - Product Realisation Planning, QMS.7.3.0 - QP - Design and Development Procedure, etc.
• A DHR is required for each manufactured product, including, but not limited to, the following information:
  • Product identification, including part/reference number or model/version number
  • Traceable control numbers, including serial number or lot number
  • Unique Device Identification (UDI) on the product label and/or direct marking
  • Dates of manufacture
  • Quantity manufactured

How will keeping a Device History Record help my organisation?

• ISO standard 13485 requires that your organisation establish and maintain records for each medical device (or batch of medical devices) that will provide traceability as well as identifying the amount manufactured and amount approved for distribution.
• This template will help you to determine your method for establishing and maintaining DHRs, as well as ensuring these records are verified and approved.

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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