The primary objective of the workshop is to educate companies about regulatory requirements that may be overlooked and guide them on the necessary steps for compliance throughout the product development process. Human factors validation testing stands out as one of the more costly tests mandated by regulatory authorities. Surprisingly, despite this, approximately 90% of the usability testing submitted to the FDA is rejected the first time around, often due to a lack of understanding of the human factors process.

Harvey Medical will be facilitating the workshop, incorporating specific case studies from members involved in the development of medical devices or software categorized as medical devices.

About our guest speakers:

Louisa has been in the medical device industry for 20 years. She founded Harvey Medical (a ClariMed company), a world-leading human factors and market insights company. Their research ensures products are developed to be safe, easy, and effective for use, evidence of which is required by regulators.

Magda is an accomplished Human Factors Researcher and Artificial Intelligence Specialist with a foundational background in psychology and social research. Her current focus lies in pioneering the integration of Human Factors and AI within the medical device industry, specifically targeting improvements in human-computer and human-robot interaction.

Program will be published soon.