09:00 - 14:00
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
8h30 – Coffee Mingle
9h00 – Opening/Scene Setter
Natale Rolim, EU Project Manager at NHT
09h15 – Human Factors (Usability) Requirements for Medical Devices, Software as a Medical Device, and AI as a Medical Device
Louisa Harvey, Founder at Harvey Medical
10h00 – How AI is Shaping the Future of Medical Device Design
Magda Skowronek, Human Factors Researcher and AI Specialist at Harvey Medical
10h15 – Q & A
Louisa Harvey and Magda Skowronek
10h30 – Coffee break
Applying Human Factors and Usability Engineering
10h40 – Case Study on Class I Medical Device: Colic Button
11h00 – A Case Study on Class II Medical Device: Sensocure
11h30 – A Case Study on Class II Software as a Medical Device: Medicue
12h00 – Drink, Snacks & Networking
12h30 – 1:1 speed meetings with Harvey Medical
Påmelding