For medical device manufacturers with limited previous experience in usability engineering, the task of implementing IEC 62366-1 might seem intimidating. However, the updated 2015 version of the standard has simplified and clarified the required process steps and tasks and Aligned Elements now features a preconfigured IEC 62366-1:2015 setup that integrates the inputs, outputs and risk relevant elements of the usability process into the oveall Design Control traceability.
The IEC 62366-1:2015 configuration includes:
- 8 Design Control templates for capturing the input and output elements of the usability process
- Pre-configured content validation checks assessing the consistency of the project in real-time
- ISO 14971 compliant risk management to identify, assess and mitigate Use Error-driven risks
- Interactive Checklist for reviewing the Use Specifications Document against IEC 62366-1:2015
- 20 usability example risks for Use Errors during the Transport, Storage, Installation and Decommissioning
- 2 preconfigured Traceability Tables
- Integrated test protocols for established test methods such as:
- Cognitive Walkthrough
- Heuristic Evaluation (based on the Nielsen-Schneidermann heuristics)
- Simulated-Use Testing for Usability Validation
The Aligned Elements IEC 62366-1:2015 configuration supports documentation management of:
- User Requirements and Specifications
- 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)
Note! The Aligned Elements IEC 62366 configuration is a significantly large extension to apply.
To get the proper understanding of the extension aspects, we strongly recommend that you book a live demonstration of the Aligned Elements IEC 62366 configuration, please This email address is being protected from spambots. You need JavaScript enabled to view it. to set up an appointment.
