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 System Requirement type Work Item.

System Requirement

Description

A system requirement according to clause 5.1 of IEC 62304:2006. Any issue of this type must be linked to its child software requirement, if it the system requirement is fulfilled by software.

Workflow Steps

The System Requirement Work Item uses the standard Evaluation Workflow.

Traceability & Impact

A System Requirement Work Item has an impact on a Software Requirement.
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 evaluation can be requested:

Attribute Name	Type	Description

Evaluation Attributes

The following custom fields must be filled out before evaluation 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.

Evaluation Checklist

The following checklist must be filled out before evaluation 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
Approved	The system requirement has been approved and needs to be implemented.
Not Approved	The system requirement has not been approved. No further action is needed.
Obsolete	The system requirement 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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