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Relevant documents for software medical device

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Guest user Created:   Sep 17, 2021 Last commented:   Sep 20, 2021

Relevant documents for software medical device

I think I know the answer to this question but I want to make sure. Are below documents relevant for a medical device that is a software or may I exclude them:

  • Appendix 4 – Request and Order for Purchasing
  • Appendix 1 – Product Specification
  • Procedure for Production and Service Provision
  • Appendix 4 – Notification to a Customer about Changes on Property
  • Procedure for EtO Sterilization
  • Procedure for Steam Sterilization
  • Procedure for Dry Heat Sterilization
  • Procedure for Ionizing Radiation Sterilization
  • Procedure for Filtration Sterilization
  • Appendix 1 – Record for Sterilization
  • Warehousing Procedure
  • Appendix 1 – Record for Temperature and Humidity Control

Adding these documents too (which are marked as mandatory but they don't relate to an app?):

  • Appendix 6 – Record of Medical Device Installation
  • Appendix 7 – Record of Servicing Activities
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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.

Expert
Kristina Zvonar Brkić Sep 20, 2021

Following documents you do not need definitely:

  • Procedure for EtO Sterilization
  • Procedure for Steam Sterilization
  • Procedure for Dry Heat Sterilization
  • Procedure for Ionizing Radiation Sterilization
  • Procedure for Filtration Sterilization
  • Appendix 1 – Record for Sterilization
  • Appendix 4 – Notification to a Customer about Changes on Property

Documents listed below you might need when taken into consideration following comments:

  • Appendix 4 – Request and Order for Purchasing –  If you use specific programs for software programming and need some licenses for then you need to order some education or similar. Also, if you use cloud service or have a server at your place, then you need to order some specific elements, so you will need a form Request and order for purchasing.
  • Appendix 1 – Product Specification – You need this because your software is your product and you know which specification that software has to have.
  • Procedure for Production and Service Provision – This procedure is a procedure where you will describe how you will program your software, who is involved in it, how you will solve bugs, and so on.
  • Warehousing Procedure –  if you do not use computers, motherboards, hardware, or anything like that, then you do not need a warehouse.
  • Appendix 1 – Record for Temperature and Humidity Control –  If you use a server room then it is necessary for the server to be in an appropriate environment (temperature and humidity). In that case, you need to monitor the temperature and humidity in that room.
  • Appendix 6 – Record of Medical Device Installation –  If the customer makes his own installation of the app, then you do not need these records.
  • Appendix 7 – Record of Servicing Activities –  Take into consideration that services in your case are solving bugs. So, you probably have some process of receiving customer complaints and the process of solving those bugs. You can then customize this form to your needs.

Just a note, that for each ISO 13485:2016 requirement that you define is not applicable for you, you need to write a justification in the Quality Manual why it is not applicable. For example, for the requirement for 7.5.5 Particular requirement for sterile medical devices, you will state that your medical device is software and that it does not require sterilization.

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Sep 17, 2021

Sep 20, 2021

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