The transition period from MDD to MDR comes to an end on May 26th, 2021. Among the many regulatory changes, the role of human factors is greatly enhanced. Manufacturers are expected to show evidence of complying with explicit, clearly defined requirements for use-related safety. And notified bodies are expected to examine your usability work closely.
The clock is ticking, but there is still time to get your human factors and usability engineering processes in shape. In this webinar, Richard Featherstone (Research Director) and Yvonne Limpens (Managing Human Factors specialist) from Emergo by UL’s human factors research and design team will review the role of usability engineering in MDR, highlighting the key requirements.
They will describe the implications for your usability work, and provide a ‘road-map to MDR compliance’ from a human factors perspective, finishing up with some ‘top tips’ for the months ahead as we approach the end of MDD to MDR transition.
This webinar was recorded on January 23, 2020.