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 Evaluation Workflow.
Traceability & Impact
For more information on traceability and impacts, see the Traceability wiki page.
Special hyperlink roles
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.
URL of additional information about the tool.
Work Item Attributes
The following custom fields must be filled out before evaluation can be requested:
Name of the tool.
Name of the tool's manufacturer.
Unique identification of the tool, i.e. a version number.
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:
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:
Ready For Use
The tool has been evaluated and can be used in the product.
The tool has become obsolete and is no longer needed.
The work item entry has been discarded. No further attention is needed.