Morris Medical Monday: Polarion MedPack and Regulatory Compliance Part 3

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
6.2.1.1 Monitor feedback	Feedback
6.2.1.2 Document and EVALUATE feedback	Feedback – Action, Problem Report – Attributes
6.2.1.3 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 Software RISK MANAGEMENT PROCESS
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 VERIFICATION of RISK CONTROL measures
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:
http://extensions.polarion.com/extensions/31-polarion-alm-medpack-iec-62304I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article.