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Medical Device Usability Testing

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In accordance with the requirements of ISO/IEC 62366:2007 and the FDA’s draft guidance document, we have designed and conducted successful formative and summative (validation) usability tests for manufacturers across Europe and United States.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

  • BulletEngage with stakeholders
  • BulletDetermine goals for product
  • BulletGather requirements from known sources

Preliminary Analysis

  • BulletConduct heuristic evaluation/expert review
  • BulletReview¬†critical risk factors
  • BulletDetermine target user groups
  • BulletIdentify tasks for testing

Formative Usability Testing

  • BulletEngage with stakeholders to plan the study
  • BulletDetermine users, tasks, environments
  • BulletEstablish critical risk factors
  • BulletConduct testing and analysis
  • BulletRecommend changes

Human Factors Validation Testing

  • BulletPlan study/develop test protocol
  • BulletUse uFMEA to identify critical risk factors
  • BulletConduct testing to determine root causes of errors
  • BulletPrepare formal report of findings

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