We will start with a general introduction about the MedPack and in the next weeks we will have a deeper look into its components.
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What is MedPack?<\/H2>
\nMedPack is a template for medical software projects managed in Polarion ALM<\/A>. 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.
\nMedPack Kernel<\/H2>
\nThe MedPack Kernel helps projects to be compliant in the three main requirements of the IEC 62304<\/B> standard for software lifecycle processes:<\/p>\n
Deliverables:<\/B> MedPack provides specific Work Item types with attributes as containers for all required deliverables.<\/p>\n
Traceability:<\/B> MedPack provides specific link roles to link Work Items of the above types to fulfill traceability requirements.<\/p>\n
Reviews:<\/B> 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.<\/p>\n
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.
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<\/p>\n![\"MedPack\"](\"http:\/\/community.plm.automation.siemens.com\/legacyfs\/online\/siemensplm_blogs\/2014\/04\/MedPack.png\")
<\/A><\/p>\nFor more information about Polarion\u00b4s MedPack visit our Extension Portal using following link:
\nhttp:\/\/extensions.polarion.com\/extensions\/31-polarion-alm-medpack-iec-62304<\/A>
\nI hope you liked this article and you will visit our blog again for the next installment of Morris Medical Monday<\/SPAN>.<\/p>\n <\/p>\n
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\nFREE INFO FOR MEDICAL DEVICE DEVELOPERS<\/P>
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![\"Report](\"http:\/\/www.polarion.com\/resources\/img\/dlcovers\/Medical-Device-Solution-Polarion-Customers-Achieve-FDA-CFR-21-Part-820-Compliance.pdf.jpg\")
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\nHow to Achieve FDA 21 Part 820 Compliance with Polarion<\/A><\/P>
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\nThe MedPack Kernel helps projects to be compliant in the three main requirements of the IEC 62304<\/B> standard for software lifecycle processes:<\/p>\n
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For more information about Polarion\u00b4s MedPack visit our Extension Portal using following link: <\/p>\n <\/DIV><\/p>\n FREE INFO FOR MEDICAL DEVICE DEVELOPERS<\/P> How to Achieve FDA 21 Part 820 Compliance with Polarion<\/A><\/P><\/A><\/p>\n
\nhttp:\/\/extensions.polarion.com\/extensions\/31-polarion-alm-medpack-iec-62304<\/A>
\nI hope you liked this article and you will visit our blog again for the next installment of Morris Medical Monday<\/SPAN>.<\/p>\n
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