Usability

Lab testing product safety and usability factors

We prioritize product usability and safety-critical tasks by employing stringent IEC 62366-1 requirements, ensuring that every piece of documentation meets the necessary standards for following FDA guidelines and gaining clearance. 

This includes home-use devices, which require rigorous lay-person testing. We’re able to provide any and all documentation and testing for usability compliance and have authored documents for product approvals since 2008–well before the FDA Guidances in 2011 and 2016.

  • IEC 62366-1:2015 Compliance

  • Usability Process Development

  • Usability Engineering Plans

  • Usability Risk Assessments

  • Formative Test Protocols

  • Pre-Summative Test Protocols

  • Summative Test Protocols

  • Usability Test Reports

  • HFE Reports

Additional Services

Project Management

Leading your team or helping you build a new one, to design and develop your product to your exact specifications.

Risk Management

Aiding your risk management planning and analyses to support new or existing products.

Software Quality

Providing IEC 62304-compliant deliverables and quality oversight on processes and execution.