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.

Detailed Design

Description

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.

Workflow Steps

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.

Attributes

Work Item Attributes

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

Attribute Name	Type	Description

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
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)

Possible Resolutions

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

Resolution Name	Description
Done	The detailed design has been completely finished.
Obsolete	The detailed design 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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