Human Factors Engineering: The Worldwide Guide for Medical Device Manufacturers

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.

Specifically this webinar will cover:

• 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.

Who should attend?

• Medical Device Executives

• Regulatory Affairs Professionals

• R&D Professionals

• Quality Professionals

• Human Factors or User Experience (UX) Professionals