My career has been built in high-stakes environments: 17 years of managing complex projects in high-end events, followed by 13 years devoted to the commercial and marketing development of medical devices. Two demanding worlds, but the same logic of value creation:...
I am a Biomedical engineer with a focus on Quality and Regulatory Affairs, particularly in the implementation and improvement of maangement systems aligned with ISO 9001 and ISO 13485 standards. I have contributed to QARA projects in both medical device and...
Theme Artificial intelligence Target Audience Manufacturers, notified bodies, competent authorities Products concerned MD and IVD integrating artificial intelligence systems (AIS) In June 2025, the MDCG published a guide concerning the interconnection between the MD...
Theme Performance studies Target Audience Sponsors of performance studies, manufacturers Products concerned IVD The MDCG published a question and answers document in June 2025 regarding performance studies of in vitro diagnostic (IVD) medical devices conducted under...
Theme Making available medical device software applications on the market Target Audience Suppliers of medical device software application platforms Products concerned MD and IVD software applications In June 2025, the MDCG published a guide describing the roles and...
Area Publication or last update date Source organization Text Applied to the DM sector Key words Int 2025 IMDRF Good Machine Learning Practice for Medical Device Development: Guiding Principles x AI, developpment Int 2024 IMDRF Good machine learning practice for...
Graduated from an engineering school in Biomedical Sciences, I have always been interested in technological advancements serving healthcare. I then chose to specialize in clinical research to be more closely involved in the benefits brought to patients. I worked as a...
This table lists all the documents published by the Medical Devices Coordination Group (MDCG), and helps to know at a glance the theme, the target audience and the type of MD concerned for each document. Would you like to know more? Find the complete summary of each...
Theme EMDN Target Audience Manufacturer, competent authorities, notified bodies Products concerned MD, IVD In January 2025, the MDCG published an excel table showing the revision history of all EMDN codes added, deleted or modified in 2024.
Theme EMDN Target Audience Manufacturer, competent authorities, notified bodies Products concerned MD, IVD In January 2025, the MDCG published a document presenting the results of the analysis of submissions made during the annual procedure for revising the European...
