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.

Software System

Description

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.

Workflow Steps

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.

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)	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).

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

Possible Resolutions

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

Resolution Name	Description
Implemented	The software system has been implemented.
Obsolete	The software system 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-62304I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article

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