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 Item type Work Item.

Software Item

Description

A description of a software item according to clause 3.25 of IEC 62304:2006. Any issue of this type must be linked to the parent software system(s) and the child software unit(s). In the case that this item is a SOUP, a link to the SOUP issue must be provided as well. See the note in clause 3.25 for further information about software decomposition.

Workflow Steps

The Software Item Item uses the standard Verification Workflow.

Traceability & Impact

A Software Item Work Item must be traceable to a Software System Work Item, to a Architectural Design or to another Software Item Work Item and has an impact on a Integration Test Work Item and to a Hazardous SituationWork Item. It can also has an impact to a SOUP Work Item, to a Software Unit Work Item or to another Software Item Work Item.
For more information on traceability and impacts, see the Traceability wiki page.

Attributes

Work Item Attributes

The following custom fields must be filled out before verification can be requested:

Attribute Name	Type	Description
Software Safety Class	Enum (A,B,C,Inherit)	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) – Inherit (Software Item inherit software safety class from linked Software System or Software Item) (as required by IEC 62304:2006->4.3).
Rationale for classification other than ‘inherited’	Text	It has to declare a reason, if a Software Item has another software safety class as ‘inherit’. (as required by IEC 62304:2006->4.3d)
Segregation to other items concerning risk control [C]	Text	A effectively segregation to other Software Items concerning risk control. (as required by IEC 62304:2006->5.3.5)

Verification Attributes

The following custom fields must be filled out before verification can be finshed and the work item can be closed:

Attribute Name	Type	Description
Reviewer	Text	Person(s) to perform, performing or have performed a review.
Review summary	Text	Short summary of the review. Attachments should be used for additional information.
Last review date	Date	Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.

Verification Checklist

The following checklist must be filled out before verification can be finshed and the work item can be closed:

Checklist entry	Description
Incorrect or incomplete specification of functionality has been taken into account	Identify potential causes of contribution to a hazardous situation (as required by IEC 62304:2006->7.1.2a)
Software defects in the identified software item functionality has been taken into account	Identify potential causes of contribution to a hazardous situation (as required by IEC 62304:2006->7.1.2b)
Failure or unexpected results from SOUP has been taken into account	Identify potential causes of contribution to a hazardous situation (as required by IEC 62304:2006->7.1.2c)
Hardware failures or other software defects that could result in unpredictable software operation has been taken into account	Identify potential causes of contribution to a hazardous situation (as required by IEC 62304:2006->7.1.2d)
Reasonably foreseeable misuse has been taken into account	Identify potential causes of contribution to a hazardous situation (as required by IEC 62304:2006->7.1.2e)

Possible Resolutions

The following table shows the possible resolution values when the work item is closed:

Resolution Name	Description
Implemented	The software item has been implemented.
Obsolete	The software item has become obsolete and is no longer needed.
Discarded	The work item entry has been discarded. No further attention is needed.

For more information about Polarion’s MedPack visit our Extension Portal using following link:
http://extensions.polarion.com/extensions/31-polarion-alm-medpack-iec-62304. I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article.

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