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The Aligned Elements IEC 62366 Usability Configuration

With the 2015 update of the IEC 62366-1:2015 and the issuing of the FDA  Human Factor Guidance, usability engineering in medical device development has received increased attention recently.

Human factor analysis gets more important with the rising trend of offering patient-centric solutions via new mobile health applications and wearables.
When patients, rather than specialists become the medical device user, increased focus needs to be placed on the patients capabilities and the environment in which the device is used. IEC 62366-1 is applied in an effort to increase patient and user safety by identifying, assessing and mitigating Use Errors, by paying attention to the usability of the device design and harness existing usability verification and validation methods to make sure that usability requirements are met and use errors are avoided.

usability

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 Element now features a preconfigured setup that integrates the inputs, outputs and risk relevant elements of the usability process into the oveall Design Control traceability.

The 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

On top of all that, the Aligned Elements IEC 62366 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 62366-1 configuration to your Aligned Elements setup, you can efficiently leverage Aligned Elements in your IEC 62366-1 compliance effort.

The Aligned Elements IEC 62366 configuration is available for download in our extension library.

For 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.

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