Optimize your medical device with comprehensive usability engineering services

In the medical device industry, usability plays a critical role in ensuring patient safety and device effectiveness. 

Adopting a structured usability engineering process, as outlined in IEC 62366-1, is essential for identifying and minimizing user-related risks throughout the product lifecycle. At Valicare, we provide specialized consulting services to help manufacturers design intuitive and user-friendly medical devices that meet regulatory requirements and enhance user experience.

Our IEC 62366 usability engineering services include:

• Usability engineering process implementation
  We help establish a usability engineering framework tailored to your organization, focusing on identifying and addressing potential user errors in compliance with IEC 62366-1.
• User needs and task analysis
  Our experts conduct in-depth analyses to understand user needs, intended uses, and operational contexts, forming the foundation for safe and effective device design.
• Usability risk assessment
  We identify potential usability risks that could compromise safety or performance, evaluating the probability and severity of harm to ensure risks are effectively mitigated.
• Formative and summative evaluations
  Valicare supports iterative usability testing during the design phase (formative evaluations) and final validation testing (summative evaluations) to ensure your device meets user expectations and regulatory standards.
• Human factors documentation
  We assist in creating and maintaining comprehensive usability engineering files, including use specifications, risk analyses, validation reports, and records required for regulatory submissions.
• Training and support
  Empower your team with tailored training programs on usability engineering principles, IEC 62366 requirements, and best practices for designing user-centered medical devices.