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 Anomaly Work Item.

Anomaly

Description

An anomaly according to clause 5.6.8 of the IEC 62304:2006. An issue of this type contains a description of an anomaly that has been discovered during integration or a system test. It must be linked to a test and a resulting problem report.

Workflow Steps

The Anomaly Work Item uses the standard Evaluation Workflow.

Traceability & Impact

An Anomaly Work Item must be traceable to either a SW System Test Work Item or an Integration Test Work Item and has an impact on a Problem Report.
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: None

Evaluation Attributes

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

Evaluation Checklist

The following checklist must be filled out before evaluation can be finished and the work item can be closed: None

Possible Resolutions

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

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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