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Morris Medical Monday: Polarion MedPack and Regulatory Compliance
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 sol...
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. 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.
Today we will have a look on chapter 4 and 5.1 and what will be covered by Polarion MedPack:
Mapping of IEC 62304 to MedPack
| Chapter of IEC 62304:2006 | Fulfilled by MedPack through: |
| 4 General requirements | |
| 4.1 Quality management system | Wiki page: Quality Management System |
| 4.2 RISK MANAGEMENT | 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) |
| 4.3 Software safety classification | Attribute “Software Safety Class” of Work Item Software System and Work Item Software Item |
| 5 Software development PROCESS | |
| 5.1 Software development planning | |
| 5.1.1 Software development plan | Wiki page: Software Development Plan |
| 5.1.2 Keep software development plan updated | Wiki page: Software Development Plan |
| 5.1.3 Software development plan reference to SYSTEM design and development | Wiki page: Software Development Plan |
| 5.1.4 Software development standards, methods and tools planning | Wiki page: Software Development Plan |
| 5.1.5 Software integration and integration testing planning | Wiki page: Software Integration Plan |
| 5.1.6 Software VERIFICATION planning | a) all Work Item Types b) Work Item Workflows c) Wiki page: Software Development Plan d) Attributes of the Work Item Types, Wiki page: Software Development Plan |
| 5.1.7 Software RISK MANAGEMENT planning | Wiki page: Risk Management File |
| 5.1.8 Documentation planning | all Work Item Types with optional attachments |
| 5.1.9 Software configuration management planning | MedPack by design |
| 5.1.10 Supporting items to be controlled | Work Item: Tool |
| 5.1.11 Software configuration item control before verification | MedPack by design through subversion |
