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Mandatory documents

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Guest user Created:   Oct 11, 2019 Last commented:   Oct 13, 2019

Mandatory documents

!Quick question: certain of the documents do not appear to apply to me but they are marked as mandatory – for example, #12 re: sterilization. Of course, as a software company, I am not involved in any such activity, so I presume it is mandatory for audit if you are involved in sterilizing MDs? Or is it that I need to have such a document in my company repertoire, even if I don’t use it (to meet the standard)?!

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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 13, 2019

No, you do not need those documents. It is just necessary to state in the Quality manual which requirements are not applicable for you and why. For example, you will state in your Quality manual that requirement 7.5.5 Particular requirements for sterile medical device is not applicable for you because you do not produce sterile medical devices.

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Oct 11, 2019

Oct 13, 2019

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