17 - 20 February, 2020 | Mercure Hotel MOA Berlin, Berlin, Germany
Johan Ordish, Senior Policy Analyst (Law & Regulation) at PHG Foundation
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Johan Ordish


Senior Policy Analyst (Law & Regulation)
PHG Foundation

Check out the incredible speaker line-up to see who will be joining Johan.

Download The Latest Agenda

Main Conference Day Two

Wednesday, February 19th, 2020


4:05 PM Machine learning as a medical device

• Examine what challenges machine learning poses for the Medical Devices Regulation, In Vitro Diagnostic
 Medical Device Regulation, and associated harmonised standards
 • Consider that a subset of machine learning models are ‘black boxes’ and that the current medical device
 framework does not adequately address interpretability in terms of clinical evidence and risk assessment
 • Recognise that a subset of machine learning models are ‘adaptive’ and that fully adaptive devices that retrain
 constantly are a poor fit with current change management processes - some creativity to remain compliant will
 be required