{"id":960,"date":"2014-05-12T18:25:30","date_gmt":"2014-05-13T01:25:30","guid":{"rendered":"https:\/\/blogs.plm.automation.siemens.com\/t5\/Polarion-Blog\/Morris-Medical-Monday-Polarion-MedPack-and-Regulatory-Compliance\/ba-p\/380856"},"modified":"2026-03-26T05:32:48","modified_gmt":"2026-03-26T09:32:48","slug":"morris-medical-monday-polarion-medpack-and-regulatory-compliance-part-3","status":"publish","type":"post","link":"https:\/\/blogs.sw.siemens.com\/polarion\/morris-medical-monday-polarion-medpack-and-regulatory-compliance-part-3\/","title":{"rendered":"Morris Medical Monday: Polarion MedPack and Regulatory Compliance Part 3"},"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. Last week we already had a look into the rest of chapter 5.<\/p>\n

Today we will have a look on chapter 6 and 7 and what will be covered by Polarion MedPack:
\nMapping 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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6 Software maintenance PROCESS<\/TD>
\n<\/TR>
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6.1 Establish software maintenance plan<\/TD>
\n		Wiki page: Software Maintenance Plan<\/TD>
\n<\/TR>
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6.2 Problem and modification analysis<\/TD>
\n		<\/TD>
\n<\/TR>
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6.2.1 Document and EVALUATE feedback<\/TD>
\n		<\/TD>
\n<\/TR>
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6.2.1.1 Monitor feedback<\/TD>
\n		Feedback<\/TD>
\n<\/TR>
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6.2.1.2 Document and EVALUATE feedback<\/TD>
\n		Feedback – Action, Problem Report – Attributes<\/TD>
\n<\/TR>
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6.2.1.3 Evaluate PROBLEM REPORT’S affects on SAFETY<\/TD>
\n		Problem Report – Attribute<\/TD>
\n<\/TR>
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6.2.2 Use software problem resolution PROCESS<\/TD>
\n		Polarion ALM by design<\/TD>
\n<\/TR>
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6.2.3 Analyse CHANGE REQUESTS<\/TD>
\n		Change Request – Attribute<\/TD>
\n<\/TR>
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6.2.4 CHANGE REQUEST approval<\/TD>
\n		Change Request – Actions<\/TD>
\n<\/TR>
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6.2.5 Communicate to users and regulators<\/TD>
\n		Change Request – Attribute<\/TD>
\n<\/TR>
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6.3 Modification implementation<\/TD>
\n		<\/TD>
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6.3.1 Use established PROCESS to implement modification<\/TD>
\n		Software Unit – Attribute<\/TD>
\n<\/TR>
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6.3.2 Re-release modified SOFTWARE SYSTEM<\/TD>
\n		Subversion \/ Polarion ALM by design<\/TD>
\n<\/TR>
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7 Software RISK MANAGEMENT PROCESS<\/TD>
\n<\/TR>
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7.1 Analysis of software contributing to hazardous situations<\/TD>
\n		<\/TD>
\n<\/TR>
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7.1.1 Identify SOFTWARE ITEMS that could contribute to a hazardous situation<\/TD>
\n		Implementation (Software System, Software Item, Software Unit, SOUP), link to Hazardous Situation<\/TD>
\n<\/TR>
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7.1.2 Identify potential causes of contribution to a hazardous situation<\/TD>
\n		Software Item – Attributes<\/TD>
\n<\/TR>
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7.1.3 EVALUATE published SOUP ANOMALY lists<\/TD>
\n		SOUP – Attribute \/ link role<\/TD>
\n<\/TR>
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7.1.4 Document potential causes<\/TD>
\n		Hazardous Situation – Attribute<\/TD>
\n<\/TR>
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7.1.5 Document sequences of events<\/TD>
\n		Hazardous Situation – Attribute<\/TD>
\n<\/TR>
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7.2 RISK CONTROL measures<\/TD>
\n		<\/TD>
\n<\/TR>
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7.2.1 Define RISK CONTROL measures<\/TD>
\n		Risk Control Measures<\/TD>
\n<\/TR>
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7.2.2 RISK CONTROL measures implemented in software<\/TD>
\n		Risk Control Measure – Attributes Wiki page: Missing Traceability Report<\/TD>
\n<\/TR>
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7.3 VERIFICATION of RISK CONTROL measures<\/TD>
\n		<\/TD>
\n<\/TR>
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7.3.1 Verify RISK CONTROL measures<\/TD>
\n		Risk Control Measure – Actions<\/TD>
\n<\/TR>
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7.3.2 Document any new sequences of events<\/TD>
\n		Risk Control Measure – Attributes<\/TD>
\n<\/TR>
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7.3.3 Document TRACEABILITY<\/TD>
\n		Wiki page: Missing Traceability Report<\/TD>
\n<\/TR>
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7.4 RISK MANAGEMENT of software changes<\/TD>
\n		<\/TD>
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7.4.1 Analyse changes to MEDICAL DEVICE SOFTWARE with respect to SAFETY<\/TD>
\n		Software Item – Attributes<\/TD>
\n<\/TR>
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7.4.2 Analyse impact of software changes on existing RISK CONTROL measures<\/TD>
\n		Software Item – Attributes<\/TD>
\n<\/TR>
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7.4.3 Perform RISK MANAGEMENT ACTIVITIES based on analyses<\/TD>
\n		Manual Attention: Overall risk (analysis) management is not done by MedPack<\/TD>
\n<\/TR>
\n<\/TBODY>
\n<\/TABLE>
\nFor more information about Polarion’s MedPack visit our Extension Portal using following link:
\nhttp:\/\/extensions.polarion.com\/extensions\/31-polarion-alm-medpack-iec-62304<\/A>I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday <\/B>article.<\/p>\n","protected":false},"excerpt":{"rendered":"

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