Yes, it is common to handle separable parts of software separately. It can be particularly useful when different parts of the software have different risk classifications per IEC 62304. Then the higher-risk parts will have all the necessary treatment for higher-risk software, while the lower-risk parts require less effort.
If you approach it this way, it's important to define the interfaces clearly, as well as being clear about the reasons for assigning each risk level. And you still need to do some validation of the whole system, after you put the parts together.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 07-Feb-2019 23:40
From: Anjali Nair
Subject: Multi-level Design Controls
Hello!
Hope you're all doing well.
My firm's product is a Software as a Medical Device. Their Design Controls are split into 4 parts: 2 accessories and 2 components.
So subpart 1 has a separate set of design inputs and outputs Same goes for subpart 2, component 1 and component 2.
Is this Multi-level Design Controls?
Also, this is the first time I'm coming across a split up Design Controls. Would this be acceptable for a 510 (k) and is this recommended?
Thanks
Regards,
Anjali Nair
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Anjali Nair
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