Welcome back to Morris Medical Monday: a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.
Today we will continue on the subject of Polarion's MedPack extension, and have a look into MedPack's Detailed Design Work Item.
A detailed design description according to clause 5.4 of the IEC 62304:2006. The detailed design must clarify the relationship between the software items and the software units. Any issue of this type must be linked to the architectural design it states more precisely and the software item and software unit entries it describes. A detailed design must only be provided in case of a class C project.
The Detailed Design Work Item uses the standard Verification Workflow.
Traceability & Impact
A Detailed Design Work Item must be traceable to a Architectural Design Work Item and has an impact on a Software Unit Work Item.
For more information on traceability and impacts, see the Traceability wiki page.
Work Item Attributes
The following custom fields must be filled out before verification can be requested:
The following custom fields must be filled out before verification can be finshed and the work item can be closed:
Person(s) to perform, performing or have performed a review.
Short summary of the review. Attachments should be used for additional information.
Last review date
Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.
The following checklist must be filled out before verification can be finshed and the work item can be closed:
Detailed Design describes interfaces
Detailed Design describes interfaces between software units and interfaces between software units and external components.
(as required by IEC 62304:2006->5.4.3)
Detailed Design implements the architecture
(as required by IEC 62304:2006->5.4.4a)
Detailed Design is free from contradictions to the software architecture
(as required by IEC 62304:2006->5.4.4b)
The following table shows the possible resolution values when the work item is closed:
The detailed design has been completely finished.
The detailed design has become obsolete and is no longer needed.
The work item entry has been discarded. No further attention is needed.