FoGia
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Hello,
I'm struggling to come up with a good and consistent approach related to risk analysis for devices that are accessories to unspecified broader systems(and which are registered as separate medical devices). Example: treatment planning software which can interface with different treatment modalities.
I'm facing two problematic scenarios:
In the later case the frequency and in some cases the severity of the risk is impacted by the other components of the system. Again is it possible to stick then to the failure mode and better not mention harms?
I'm looking forward your thoughts on this.
Best regards
I'm struggling to come up with a good and consistent approach related to risk analysis for devices that are accessories to unspecified broader systems(and which are registered as separate medical devices). Example: treatment planning software which can interface with different treatment modalities.
I'm facing two problematic scenarios:
- Accessory with no specific medical indication
- Accessory intended for a specific medical indication
In the later case the frequency and in some cases the severity of the risk is impacted by the other components of the system. Again is it possible to stick then to the failure mode and better not mention harms?
I'm looking forward your thoughts on this.
Best regards