Digital health devices have been on the rise since a couple of years, ranging from different kinds of wearables to stand alone software applications, able to capture body parameters, made available for analysis and translated into actionable “health status” information for consumers. (patient, health & social care professionals or a lay person).
During this workshop Steve Eglem and Johan Goris will provide basic insight about different aspects for you to take into account to be able to choose a fitted legal pathway.
Your health & medical software devices might be covered by a medical device directive (MDD or IVD) or considered a consumer product (GPSD), depending on your product claims.
This workshop will focus on regulatory aspects, classification, validation and conformity assessment procedures, including the risk assessment and risk management approach following applicable standards and how to deal with them for such products.
Steve and Johan will also check the future legal framework of medical devices (regulation 745/2017 and 746/2017), point at the impact of the coming regulation about data protection (GDPR) and situate the health & medical software product safety risks from cyber-vulnerability in general.