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 Feedback Work Item type.

Feedback

Description

User or market feedback according to clause 6.2.1.2 of IEC 62304:2006. A feedback entry might have a link to a problem report generated from it.

Workflow Steps

The Feedback Item uses the standard Evaluation Workflow.

Traceability & Impact

A Feedback Work Item 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:

Attribute Name	Type	Description
Feedback source	Enum	A Feedback has to be classify in the the following “feedback source”-categories: – inside organisation – outside organisation (customer) – outside organisation (user) (as required by IEC 62304:2006->6.2.1.1).

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
Needs Problem Report	Further investigation through a problem report is needed for this feedback (as required by IEC 62304:2006->6.2.1.2).
No Problem Report Needed	No further investigation through a problem report is needed for this feedback.
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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