Requirements for using Open Source Software in Medical Devices - IVD Medical Device

Marcelo

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Re: Requirements for using Open Source Software in Medical Devices - IVD Medical Devi

Great comments Peter. Some of my thoughts:

But a medical device manufacturer is allowed to trust the ADC manufacturer's specification sheet without any special provisions, despite that the design of the ADC is outside of the manufacturer's control. Don't be fooled: end product verification testing does not fully test hardware circuits - it is no different to software in that it is impossible to test all permutations - and as such a huge amount of trust is being placed in the the component manufacturers.
I know that some manufacturers blindly trust catalogues and specifications sheets, in this case they´re doing the wrong thing. Manufacturers should have control of components used in their device. This does not mean they have to control them themselves, but can require that the component manufacturer have a control, for example, following a standard in their development. In fact you usually pay more for a more "controlled' component.

This could be the same case as software. But in the case of open source, free software, you cannot expect that it have the necessary controls to demonstrate software safety. Still, i think most people expect that (with no good reason) and this i another problem.

Whether open source or not, the reliability of most OTS software is bound to be several times higher than anything written by the medical device manufacturer, simply because of its wider application. Thus, we should be encouraging the use of OTS software rather than discouraging: it would be safer in the long run.
You´re right regarding reliability, but please remember that reliability is not the same as safety. The software (and hardware) can be reliable but unsafe.


And of course, if the failure of the ADC can lead to a serious event, such as death, then the manufacturer should put into place protection that operates independent of the ADC.

On the other hand, a manufacturer that uses some off the shelf software, suddenly the world comes down on them. Does this make sense? No. In the article above about IVD and open source software, every argument raised about OTS software can be equally applied to an OTS ADC.
I think you got to the point here. There´s usually a need for extra protection on something that you, as the manufacturer, does not have control of, software or hardware. The software regulatory requirements are these "extra" protection.

But I do not see these software requirements as beyond the safety gain as you mentioned. They seem as "heavy" as hardware requirements.
 
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