Medical device users must be able to operate medical devices safely and effectively. Our full life-cycle usability testing services meet medical device manufacturers’ regulatory, standards certifications and marketing requirements.

Usability or human factors testing reveals how easy, satisfying and safe a medical device is to use. The findings not only guide design teams during design and development, but they also are required in documentation submitted to regulatory authorities.

In accordance with the requirements of ISO/IEC 62366:2007 and the FDA’s draft guidance document, we have designed and conducted successful formative and summative (validation) usability tests for manufacturers across Europe and United States.

Our Role

MakroCare provides a team of highly qualified, experienced researchers to conduct formative and summative usability testing of medical devices. Our processes ensure compliance with all regulations and guidelines in support of successful  FDA 510(k) and EU MDR CE submissions.

Requirements Gathering

  • Engage with stakeholders
  • Determine goals for product
  • Gather requirements from known sources

Preliminary Analysis

  • Conduct heuristic evaluation/expert review
  • Review critical risk factors
  • Determine target user groups
  • Identify tasks for testing

Formative Usability Testing

  • Engage with stakeholders to plan the study
  • Determine users, tasks, environments
  • Establish critical risk factors
  • Conduct testing and analysis
  • Recommend changes

Human Factors Validation Testing

  • Plan study/develop test protocol
  • Use uFMEA to identify critical risk factors
  • Conduct testing to determine root causes of errors
  • Prepare formal report of findings

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