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 Work Item Workflows.
The MedPack templates provides a custom field for risk management which is also used in the RiskPack (the risk management extension according to ISO 14971). So while being separate products, MedPack and RiskPack work seamslessly together through this custom field.
The custom field’s name is Needs to be considered by risk management and can be used to flag an item to be relevant for the safety of the product. The value of this custom field can either be ‘yes’ or ‘no’. By default, it is unset.
Important remark: The default workflow does not require this field to be set at any time! The RiskPack checks whether this field is set separately. However, is this custom field is used within your process, we recommend to make it mandatory to finish a review.
For more information about Polarion’s MedPack visit our Extension Portal using following link:
http://extensions.polarion.com/extensions/31-polarion-alm-medpack-iec-62304I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article.