The "IEC 62304 – medical device software – software life cycle processes" is a standard specifying life cycle requirements for the development of medical software and software within medical devices.
This international standard is harmonized by the EU and USA and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
Software development according to IEC 62304 is a risk-driven approach, requiring the developer to perform reliability- and safety enhancing actions and tasks proportional to the risk the software poses to the patients and users.
Getting compliant with IEC 62304 may seem daunting at first. The Aligned Elements IEC 62304 configuration has been set up to guide you through this process and has been tuned to automatically take care of most of the involved quality checks, making sure that the required tasks and actions are sufficiently covered.
The Aligned Elements IEC 62304 configurations contains:
- Pre-configured templates using IEC 62304 standard naming conventions
- Software Safety Classification automatically based on risk analysis results
- Numerous quality checks for consistency verification
- Pre-configured Reviews and checkpoints according to IEC 62304 stipulations
- Pre-configured Trace Tables based on the IEC 62304 requirements
- Included Process-checklists for documented verification of process compliance
The Aligned Elements IEC 62304 supports documentation management of:
- System and Software Requirements
- Software Architecture building blocks(Software Items, Units SOUPs and segregations)
- Risk Management using a Preliminary Hazard Analysis technique (listed in ISO 14971)
- Verification and Validation (Unit, Integration and System testing)
- Change and configuration management (Problem Reports and Change Management)
On top of all that, the Aligned Elements IEC 62304 includes all the standard features of Aligned Elements, including:
- Completed change control of all Design Control Items
- Complete audit trail for all changes
- Keep your company specific look and feel of all report outputs
- End-to-end tracability with real-time impact analysis
- Easy and fast Word reporting using drag and drop
- FDA QSR 21 CFR Part 11 compliant User Management
- Efficient decision-making process using workflows and E-signatures
By applying selected parts of the Aligned Elements IEC 62304 configuration to your Aligned Elements setup, you can efficiently leverage Aligned Elements in your IEC 62304 compliance effort.
The Aligned Elements IEC 62304 configuration is available for download in our extension library.