The following regulators from these global markets require human factors and usability engineering when developing a new medical device:
United States: Food and Drug Administration (FDA)
United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA)
European Union: Medical Device Regulation (MDR)
It can be difficult to determine (and comply with) the requirements of just one of these regulatory markets, let alone all three.
Indeed, medical device manufactures may (or may not!) fully understand the human factors requirements unique to their native markets, but the struggle tends to worsen when trying to align compliance efforts with an entirely new set of requirements from a different, foreign regulatory body.
Join human factors engineering experts Bryant Foster and Anders Orn from Research Collective as they co-present this interactive webinar, leveraging their years of experience guiding medical device manufacturers through human factors submissions of all shapes and sizes.
This free, in-depth webinar will cover the human factors engineering process, as well as what you need to know about the process according to regulatory requirements of the United States, United Kingdom, European Union, and international standards.
Clarify who human factors engineering is required for.
Describe the human factors process.
Explain how human factors efforts should differ depending on the market.
Discuss required documentation for human factors engineering.
Medical Device Executives
Regulatory Affairs Professionals
Human Factors or User Experience (UX) Professionals
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient.
Visit our homepage to learn more.
We combine multi-industry experience and extensive training to conduct human factors research of the highest quality. With significant experience in research design, fielding, advanced statistical analysis, and actionable reporting, our team helps answer the questions clients care about, enabling them to make informed, confident decisions.
Visit their website to learn more.