Installation Process

[ISO 13485 Cl 7.5.3] 


Clause 7.5.3 of ISO 13485 emphasizes establishing and maintaining documented procedures for installation activities to ensure that medical devices are installed correctly and consistently to maintain the safety and performance of the device throughout its intended use.

The documented procedure should be defined:

  • The activities involved in the installation of the device to ensure consistency and adherence to specifications.
  • The competence required of personnel performing the installation.
  • The details of specific tools or equipment needed.
  • The verification is to confirm that the installed device meets the specified requirements and operates as intended.
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