Welcome back to the first Morris Medical Monday article of the new year. I hope you had a great holiday season. For anyone who is new to our blog, this 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 SOUP Work Item.
A description of a software component of unknown provenance (SOUP) used in the project, according to clause 3.29 of IEC 62304:2006. Any issue of this type must be linked to the software item that is implemented by the component.
The SOUP Work Item uses the standard Evaluation Workflow.
Traceability & Impact
A SOUP Work Item must be traceable to a Software Item Work Item and a Architectural Design Work Item and has an impact on an Integration Test Work Item and a Hazardous Situation Work Item.
For more information on traceability and impacts, see the Traceability wiki page.
Special hyperlink roles
A SOUP work item has special hyperlink roles to fulfill the requirements of IEC 62304. The following tables lists thos roles.
Published anomaly list
URL of an anomaly list for the used SOUP component
URL of the manufacturer's homepage.
URL of additional information about the SOUP component.
Work Item Attributes
The following custom fields must be filled out before evaluation can be requested: