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 Architectural Design Work Item.

Architectural Design

Description

The description of the architectural design according to clause 5.3 of the IEC 62304:2006. The architectural design must clarify the relationship between the software system and the software items. Any issue of this type must be linked to a software requirement and the software system and software item entries it describes. An architectural design must only be provided in case of a class B or class C project.

Workflow Steps

The Architectural Design Work Item uses the standard Verification Workflow.

Traceability & Impact

An Architectural Design Work Item must be traceable to a Software Requirement Work Item and has an impact on a Software Item Work Item, a Software System Work Item, a SOUP Work Item or a Detailed Design Work Item. It can also 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 finished 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 finished. Intended to be used for sorting and statistical analysis.

Verification Checklist

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

Checklist entry	Description
Architecture implements all requirements	The Architecture has to implement all System and Software Requirements. (as required by IEC 62304:2006->5.3.6a)
Architecture supports interfaces	The Architecture has to support interfaces between Software Items and between Software Items and hardware. (as required by IEC 62304:2006->5.3.6b)
Architecture supports proper operation of SOUP items	The Architecture has to support proper operation of SOUP Items. (as required by IEC 62304:2006->5.3.6c)

Possible Resolutions

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

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