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Verify Software Architecture - supporting interfaces between items

K

KrishQA

Starting to get Involved
#1
#1
So 62304 states that

The MANUFACTURER shall verify and document that:
a) the ARCHITECTURE of the software implements SYSTEM and software requirements including
those relating to RISK CONTROL;
b) the software ARCHITECTURE is able to support interfaces between SOFTWARE ITEMS and
between SOFTWARE ITEMS and hardware; and
c) the MEDICAL DEVICE ARCHITECTURE supports proper operation of any SOUP items.
[Class B, C]

We are reviewing the architecture document via a technical evaluation / Design review, however just need proper understanding on point b) above.

What exactly does it mean to check if the architecture can support the interfaces between software items.

Is it for example,
  • if the architect comes up with a design that tries to interface with a Bluetooth 3.0 device but the hardware does not support BT 3.0?
  • if there are two software items that are separated from each other and the interface does not define how they are to communicate with each other?

Can someone provide some examples where this verification fails? TIA
 
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T

Tidge

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#2
#2
KrishQA said:
The MANUFACTURER shall verify and document that:

b) the software ARCHITECTURE is able to support interfaces between SOFTWARE ITEMS and
between SOFTWARE ITEMS and hardware;

Can someone provide some examples where this verification fails? TIA
Click to expand...
The architecture specifies that software unit A passes information to software unit B.

If the interface between unit A and unit B is asynchronous, it is possible that unit B will not be acting on the information from unit A as necessary under all circumstances.
 
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