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.

Tool

Description

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.

Workflow Steps

The Tool Work Item uses the standard Evaluation Workflow.

Traceability & Impact

For more information on traceability and impacts, see the Traceability wiki page.

Attributes

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.

Hyperlink Role	Description
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:

Attribute Name	Type	Description
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.

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
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.

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