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IEC 62304 Section 5.3.6 Verify Software Architecture

R

raqark

#1
Hello,

I am looking for suggestions and recommendations on how to address the following requirements of IEC 62304.

IEC 62304 Cl 5.3.6 - Verify SW Architecture:

5.3.6.a The MANUFACTURER has verified and documented that the ARCHITECTURE of the software implements SYSTEM and software requirements including those relating to RISK CONTROL.

5.3.6.b The MANUFACTURER has verified and documented that the SOFTWARE ARCHITECTURE is able to support interfaces between SOFTWARE ITEMS and between SOFTWARE ITEMS and hardware.

5.3.6.c The MANUFACTURER has verified and documented that the MEDICAL DEVICE ARCHITECTURE supports proper operation of any SOUP items.


IEC 62304 Annex B.5.3 states : Verification of the architecture is generally done by technical evaluation.

What activities in a development life cycle constitute a technical evaluation to verify architecture?
 
Elsmar Forum Sponsor
#3
How did you verify your SW architecture if it wasn't by a technical evaluation?
I'm asking because you've done your verification and I think you're probably reading something into this, that isn't there.
 

glork98

Involved In Discussions
#4
The verification activities should be described in the SOPs, Work Instructions and in the Software Development Plan, first of all.

What class is your software?

To verify the software architecture you would use a variety of review and test approaches as appropriate for your code and company. I'd expect that this would include a multi-pronged approach:

* Create SW architecture document and review it
* Create SW detailed design documents and review those
* Review code against the SW architecture and designs
* Write system, unit and integration tests
* Trace the above tests to the Software Requirements and the SW Req to the System requirements

And don't forget the risk analysis of the architecture, design and code. Make sure the mitigations (tests, code additions, reviews, more...) are followed through on.
 
R

raqark

#5
Thanks everyone.

Its good to get reassurance that the verification, design review activities, traceability, etc all provide evidence of architecture verification. I might have been reading too much into it. I understand it better now. :thanks:
 
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