R
raqark
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?
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?