This is one of our foundational training courses needed for all medical device manufactures. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors team, as they relate to human factors, and the process of applying human factors in the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on the pharmaceutical industry.
Learn human factors methodologies—contextual inquiry, heuristic evaluations, formative studies, summative studies, the post-market arena, and relevant standards.
Medical device manufacturers with robust human factors processes are leading the market, proving to have better clinical outcomes and better quality. Take this course to understand critical human factors processes to consider when designing a medical device, how they affect its safety, and which steps to take to mitigate risks. FDA representatives from CDRH and CDER will speak to expectations for device usability.
21st of September 2020, Dublin, Ireland
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