Each Monday for the next several months, I'll be posting useful info for medical device companies on using Polarion and Polarion extensions to streamline development, facilitate compliance, and accelerate time to market.
In our first series of articles we will focus on Polarion´s MedPack, created by our partner Medsoto GmbH. We will get an insight into MedPack and what kind of configuration will be delivered so you can save time and money.
We will start with a general introduction about the MedPack and in the next weeks we will have a deeper look into its components.
What is MedPack?
MedPack is a template for medical software projects managed in Polarion ALM. It configures and extends Polarion ALM to help documenting and managing medical software development. The MedPack Kernel is the heart of the MedPack and consists of a set of project configurations, on top of which Wiki spaces are set up to provide different views onto, and to analyse options for the project. Both the configurations and the wiki pages can be freely modified and adapted to special needs.
The MedPack Kernel helps projects to be compliant in the three main requirements of the IEC 62304 standard for software lifecycle processes:
Deliverables: MedPack provides specific Work Item types with attributes as containers for all required deliverables.
Traceability: MedPack provides specific link roles to link Work Items of the above types to fulfill traceability requirements.
Reviews: MedPack provides specific work flows for the Work Items above to fulfill the requirements for review of all deliverables. A role model ensures that developers cannot review their own work. Workflow conditions ensure that data cannot be changed after a review has been performed, Work Item statuses enable to judge the progress and success of the overall process.
The figure below shows the deliverables, required links and review activities. Visit the help pages to the Work Item types to find out more about attributes and Work Item workflows.