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 Tool type Work Item.
A Description of a tool used for creating the medical software (compilers, builders, linkers, analysis software) and their configuration. Needed to fulfill the requirements of clause 5.1.4 and 5.1.10 of IEC 62304 for class B or C projects.
The Tool Work Item uses the standard .
Traceability & Impact
For more information on traceability and impacts, see the .
A Tool work item has special hyperlink roles to store information that can be helpfull during risk and quality management. The following tables lists thos roles.
|Published anomaly list||URL of an anomaly list for the tool.|
|Tool manufacturer URL||URL of the manufacturer’s homepage.|
|Tool URL||URL of additional information about the tool.|
Work Item Attributes
The following custom fields must be filled out before evaluation can be requested:
|Tool title||Text||Name of the tool.|
|Tool manufacturer||Text||Name of the tool’s manufacturer.|
|Tool designator||Text||Unique identification of the tool, i.e. a version number.|
|Functional requirements||Text||Functional requirements of the tool, i.e. reason to use it.|
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:
|Ready For Use||The tool has been evaluated and can be used in the product.|
|Obsolete||The tool 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.