OpenRegulatory Conference 2021
Leon Doorn, Aidence
Risk Management in Decision Support Systems
Many software systems in the medical devices field are supportive in decision making processes. This introduces a number of challenges, for example how do you effectively estimate probability of occurrence, if your device is not the single contributary cause of occurrence? Also, what can we learn from the post market surveillance process, and how should this interact with the risk assessment?
Leon is Head of Regulatory Compliance at Aidence where he is responsible for Quality, Regulatory and Information Security. He has over 14 years of experience in the medical device quality and regulatory affairs field and is a member of the ISO SC42 AI committee, working on ISO standards.