{"id":1122,"date":"2014-04-28T15:30:00","date_gmt":"2014-04-28T22:30:00","guid":{"rendered":"https:\/\/blogs.plm.automation.siemens.com\/t5\/Polarion-Blog\/Morris-Medical-Monday-Polarion-MedPack-and-Regulatory-Compliance\/ba-p\/380851"},"modified":"2026-03-26T05:35:00","modified_gmt":"2026-03-26T09:35:00","slug":"morris-medical-monday-polarion-medpack-and-regulatory-compliance","status":"publish","type":"post","link":"https:\/\/blogs.sw.siemens.com\/polarion\/morris-medical-monday-polarion-medpack-and-regulatory-compliance\/","title":{"rendered":"Morris Medical Monday: Polarion MedPack and Regulatory Compliance"},"content":{"rendered":"

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<\/A> and Polarion extensions<\/A>.<\/p>\n

Today we will continue on the subject of Polarion’s MedPack extension<\/A>, and have a look into MedPack’s compliance support.
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MedPack Compliance<\/H2>
\nMedPack helps medical device development projects to be compliant. The MedPack Kernel is an implementation of the IEC 62304<\/STRONG> (Software Lifecycle Process for Medical Devices) standard. A mapping of the IEC 62304 and the way MedPack fulfills its requirements will be described in the next few weeks to get a high level overview before we go deeper into all MedPack components.<\/p>\n

Today we will have a look on chapter 4 and 5.1 and what will be covered by Polarion MedPack:<\/p>\n

Mapping of IEC 62304 to MedPack<\/B>
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Chapter of IEC 62304:2006<\/STRONG><\/TD>
\n		Fulfilled by MedPack through:<\/STRONG><\/TD>
\n<\/TR>
\n<\/THEAD>
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4 General requirements<\/TD>
\n<\/TR>
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4.1 Quality management system<\/TD>
\n		Wiki page: Quality Management System<\/TD>
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4.2 RISK MANAGEMENT<\/TD>
\n		Risk Management Work Items (Risk Control Measure, Hazardous Situation) (Note: These only fulfill basic requirements of IEC 62304, especially concerning traceability. For a complete risk management that is fully compliant to ISO 14971, see the wiki page Risk Management Process Description)<\/TD>
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4.3 Software safety classification<\/TD>
\n		Attribute “Software Safety Class” of Work Item Software System and Work Item Software Item<\/TD>
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5 Software development PROCESS<\/TD>
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5.1 Software development planning<\/TD>
\n		<\/TD>
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5.1.1 Software development plan<\/TD>
\n		Wiki page: Software Development Plan<\/TD>
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5.1.2 Keep software development plan updated<\/TD>
\n		Wiki page: Software Development Plan<\/TD>
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5.1.3 Software development plan reference to SYSTEM design and development<\/TD>
\n		Wiki page: Software Development Plan<\/TD>
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5.1.4 Software development standards, methods and tools planning<\/TD>
\n		Wiki page: Software Development Plan<\/TD>
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5.1.5 Software integration and integration testing planning<\/TD>
\n		Wiki page: Software Integration Plan<\/TD>
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5.1.6 Software VERIFICATION planning<\/TD>
\n		a) all Work Item Types
\nb) Work Item Workflows
\nc) Wiki page: Software Development Plan
\nd) Attributes of the Work Item Types, Wiki page: Software Development Plan<\/TD>
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5.1.7 Software RISK MANAGEMENT planning<\/TD>
\n		Wiki page: Risk Management File<\/TD>
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5.1.8 Documentation planning<\/TD>
\n		all Work Item Types with optional attachments<\/TD>
\n<\/TR>
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5.1.9 Software configuration management planning<\/TD>
\n		MedPack by design<\/TD>
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5.1.10 Supporting items to be controlled<\/TD>
\n		Work Item: Tool<\/TD>
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5.1.11 Software configuration item control before verification<\/TD>
\n		MedPack by design through subversion<\/TD>
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\n<\/TABLE><\/p>\n

<\/p>\n

\"Medical<\/A><\/DIV><\/p>\n","protected":false},"excerpt":{"rendered":"

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