Morris Medical Monday: Polarion MedPack and Regulatory Compliance Part 3

By morrisd

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 compliance support.

MedPack Compliance

MedPack helps medical device development projects to be compliant. The MedPack Kernel is an implementation of the IEC 62304 (Software Lifecycle Process for Medical Devices) standard. Last week we already had a look into the rest of chapter 5.

Today we will have a look on chapter 6 and 7 and what will be covered by Polarion MedPack:
Mapping of IEC 62304 to MedPack

Chapter of IEC 62304:2006 Fulfilled by MedPack through:
6 Software maintenance PROCESS
6.1 Establish software maintenance plan Wiki page: Software Maintenance Plan
6.2 Problem and modification analysis
6.2.1 Document and EVALUATE feedback Monitor feedback Feedback Document and EVALUATE feedback Feedback – Action, Problem Report – Attributes Evaluate PROBLEM REPORT’S affects on SAFETY Problem Report – Attribute
6.2.2 Use software problem resolution PROCESS Polarion ALM by design
6.2.3 Analyse CHANGE REQUESTS Change Request – Attribute
6.2.4 CHANGE REQUEST approval Change Request – Actions
6.2.5 Communicate to users and regulators Change Request – Attribute
6.3 Modification implementation
6.3.1 Use established PROCESS to implement modification Software Unit – Attribute
6.3.2 Re-release modified SOFTWARE SYSTEM Subversion / Polarion ALM by design
7.1 Analysis of software contributing to hazardous situations
7.1.1 Identify SOFTWARE ITEMS that could contribute to a hazardous situation Implementation (Software System, Software Item, Software Unit, SOUP), link to Hazardous Situation
7.1.2 Identify potential causes of contribution to a hazardous situation Software Item – Attributes
7.1.3 EVALUATE published SOUP ANOMALY lists SOUP – Attribute / link role
7.1.4 Document potential causes Hazardous Situation – Attribute
7.1.5 Document sequences of events Hazardous Situation – Attribute
7.2 RISK CONTROL measures
7.2.1 Define RISK CONTROL measures Risk Control Measures
7.2.2 RISK CONTROL measures implemented in software Risk Control Measure – Attributes Wiki page: Missing Traceability Report
7.3.1 Verify RISK CONTROL measures Risk Control Measure – Actions
7.3.2 Document any new sequences of events Risk Control Measure – Attributes
7.3.3 Document TRACEABILITY Wiki page: Missing Traceability Report
7.4 RISK MANAGEMENT of software changes
7.4.1 Analyse changes to MEDICAL DEVICE SOFTWARE with respect to SAFETY Software Item – Attributes
7.4.2 Analyse impact of software changes on existing RISK CONTROL measures Software Item – Attributes
7.4.3 Perform RISK MANAGEMENT ACTIVITIES based on analyses Manual Attention: Overall risk (analysis) management is not done by MedPack

For more information about Polarion’s MedPack visit our Extension Portal using following link: hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article.

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This article first appeared on the Siemens Digital Industries Software blog at