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 188.8.131.52 of IEC 62304:2006. A feedback entry might have a link to a problem report generated from it.
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.
Work Item Attributes
The following custom fields must be filled out before evaluation can be requested:
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->184.108.40.206).
The following custom fields must be filled out before evaluation can be finshed and the work item can be closed:
Person(s) to perform, performing or have performed a review.
Short summary of the review. Attachments should be used for additional information.
Last review 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 IEC 62304:2006->220.127.116.11).
No Problem Report Needed
No further investigation through a problem report is needed for this feedback.
The work item entry has been discarded. No further attention is needed.