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.
User or market feedback according to clause 184.108.40.206 of IEC 62304:2006. A feedback entry might have a link to a problem report generated from it.
The Feedback Item uses the standard .
Traceability & Impact
A Feedback Work Item has an impact on a .
For more information on traceability and impacts, see the .
Work Item Attributes
The following custom fields must be filled out before evaluation can be requested:
|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 ->220.127.116.11).
The following custom fields must be filled out before evaluation can be finshed and the work item can be closed:
|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.|
The following checklist must be filled out before evaluation can be finshed and the work item can be closed:
The following table shows the possible resolution values when the work item is closed:
|Needs Problem Report||Further investigation through a problem report is needed for this feedback (as required by->18.104.22.168).|
|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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