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In accordance with the requirements of ISO/IEC 62366:2007 and the FDA’s draft guidance document, we have designed and conducted successful formative and summative (validation) usability tests for manufacturers across Europe and United States.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