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 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 6 and 7.
Today we will have a look on chapter 8 and 9 and what will be covered by Polarion MedPack:
Mapping of IEC 62304 to MedPack
|Chapter of IEC 62304:2006||Fulfilled by MedPack through:|
|8 Software configuration management PROCESS|
|8.1 Configuration identification|
|8.1.1 Establish means to identify CONFIGURATION ITEMS||Subversion / Polarion ALM by design|
|8.1.2 Identify SOUP||SOUP – Attributes|
|8.1.3 Identify SYSTEM configuration documentation||Subversion / Polarion ALM by design|
|8.2 Change control|
|8.2.1 Approve CHANGE REQUESTS||Change Request – Action “approve”|
|8.2.2 Implement changes||Change Request – Attributes, Software Item – Verification Attributes in case of changes|
|8.2.3 Verify changes||all Work Items:Workflow and status|
|8.2.4 Provide means for TRACEABILITY of change||Wiki page: Missing Traceability Report|
|8.3 Configuration status accounting||Polarion ALM by design|
|9 Software problem resolution PROCESS|
|9.1 Prepare PROBLEM REPORTS||Problem Report – Attributes|
|9.2 Investigate the problem||Problem Report – Attributes|
|9.3 Advise relevant parties||Problem Report – Attributes|
|9.4 Use change control process||Change Request – Action “approve”. Wiki page: Review Report|
|9.5 Maintain records||Polarion ALM by design|
|9.6 Analyse problems for trends||Problem Report – Attributes|
|9.7 Verify software problem resolution||Problem Report – Attributes|
|9.8 Test documentation contents||Integration Test – Attributes, Software System Test – Attributes|
MedPack also provides interfaces to the following standards:
ISO 14971 (Risk Management): MedPack supports full traceability of risk management as required by IEC 62304. However, it is not a full-flavoured risk management tool.
ISO 13485 (Quality Management): As some requirements of quality management are rather static, a dynamic ALM tool is not the perfect choice to fulfill the complete standard. However, aspects of product realisation are covered. Also, there are template pages for required process descriptions within the Regulatory Records wiki space.
As you can see we have got a lot of information to cover in the next weeks.
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.