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Medical devices vs. AI and software driven medical devices

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Guest user Created:   Feb 04, 2021 Last commented:   Feb 08, 2021

Medical devices vs. AI and software driven medical devices

if I have to establish and develop ISO 13485 for a company predominantly is AI and software driven medical devices, what are the main differences between medical device vs the above mentioned medical device.

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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 Feb 08, 2021

For medical devices that are software and AI, the following requirements are not applicable:

6.4 Work environment and contamination control
7.5.5 Particular requirements for sterile medical devices
7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems
7.5.9.2 Particular requirements for implantable medical devices
It means that you do not need to prepare documentation from these requirements. In your Quality manual, it is necessary to state which requirements are not applicable and why. For example, for requirement 7.5.5 justification can be: This requirement is not applicable because our product is not sterile, and does not need to be sterile to perform its intended use.  

The following requirements need to be seen whether they are applicable or not:

7.5.3 Installation activities
7.5.4 Service activities

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Feb 04, 2021

Feb 08, 2021