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Validation Procedure

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Guest user Created:   Oct 17, 2020 Last commented:   Oct 20, 2020

Validation Procedure

Does the pack include one and I just can't find it? Or is that something you provide separately or at all?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Oct 20, 2020

No, our pack does not include a Validation procedure. It is covered in the procedure 11_Procedure_for_Production_and_Service_Provision_Premium_EN, under section 3.2.3.

Since processes that need validation are very different it is not possible to make a uniform procedure for them all. Also, some processes have their own rules and standards on how validation must be performed (eg. each type of the sterilization has its own standard for the validation:

  • ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation, and routine control of a sterilization process for medical devices
  • ISO 11137-1:2006(en) - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

For more information on validation, you can see the following articles:

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Oct 16, 2020

Oct 20, 2020

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