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 "Software System" Work Item type.
A description of a software system according to clauses 3.27 and 3.25 of IEC 62304:2006. Any issue of this type must be linked to its child software item(s). See the note in clause 3.25 for further information about software decomposition.
The Software System Work Item uses the standard Verification Workflow.
Traceability & Impact
A Software System Work Item must be traceable to a Architectural Design Work Item and has an impact on a Software Item Work Item, a Integration Test Work Item and a Hazardous Situation 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:
Software Safety Class
A Software System have to classified in one of the following Software Safety Classes:
- Software Safety Class A (No injury or damage to health is possible)
- Software Safety Class B (Non-serious injury is possible)
- Software Safety Class C (Death or serious injury is possible)
(as required by IEC 62304:2006->4.3).
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:
The following table shows the possible resolution values when the work item is closed:
The software system has been implemented.
The software system has become obsolete and is no longer needed.
The work item entry has been discarded. No further attention is needed.