Achieving compliance to ISO:62366

ISO:62366 places a strong emphasis on the importance of usability engineering in the design and development of medical devices. Compliance ensures that manufacturers consider the needs and capabilities of users to create devices that are safe and effective in real-world clinical settings.

Tento+’s Role in ISO 62366 Compliance:

Tento+ offers a suite of features that simplify the process of achieving compliance with ISO 62366. Here’s how this tool can become your invaluable asset in this endeavour:

  1. User Requirements Management: Tento+ allows you to systematically capture and manage user requirements, ensuring that the device design is aligned with user needs.
  2. Usability Testing Planning: Create and document usability testing plans, which are a crucial aspect of ISO 62366 compliance. Define test objectives, criteria, and methods within Tento+.
  3. Usability Testing Execution: Execute usability tests in accordance with your predefined plans. Tento+ streamlines the testing process, allowing you to capture user feedback efficiently.
  4. Usability Evaluation: Gather and analyze user feedback and observations to evaluate the usability of your medical device. Document the results and findings using Tento+.
  5. Traceability: Achieving traceability between user requirements, design outputs, and usability test results is essential for ISO 62366 compliance. Tento+ offers visual traceability features to connect these elements seamlessly.
  6. Documentation and Reporting: Tento+ automates the creation of usability engineering reports, ensuring that they align with ISO 62366 requirements and facilitating the documentation process.

On top of these, you’ll also need SOPs that describe how your team works and how they handle software problems, deployment, and source management. If you are looking for hands on advice, head to our programmes page, and we will get you Compliant in 4 Weeks.