CORE-MD Podcast – How do surgeons choose which Medical Device to implant?

Alan Fraser, European Society of Cardiology, Scientific Coordinator of CORE-MD and Ass. Prof. Dr. Per Kjaersgaard-Andersen, EFORT´s Chair EU Affairs Committee, talk in this CORE-MD Podcast about How do surgeons choose which Medical Device to implant?. Also, do not miss our past CORE-MD webinar on a similar topic: “Monitoring the life cycle of an implant in […]

CORE-MD Podcast –  Understanding how EU Notified Bodies work

Alan Fraser, European Society of Cardiology, Scientific Coordinator of CORE-MD and Richard Holborow, Head of Clinical Compliance BSI Group, talk in this CORE-MD Podcast about the understanding Understanding how EU Notified Bodies work. Also, do not miss our past CORE-MD webinar on Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and […]

CORE–MD Final Conference

The CORE-MD consortium is organising its Final Conference on Friday 15 March 2024 at the De Warande Club in Brussels. This event will gather representatives from regulators, notified bodies, researchers, industry but also patients and healthcare professionals. It will notably contribute to share its insights on the clinical evaluation of high-risk medical devices based on […]

Upcoming Webinar on Early Clinical Investigation of Medical Devices

On 8th January 2024, from 17.00 CET until 18.15, the CORE-MD consortium organises its tenth free webinar entitled “Early clinical investigations of new high-risk medical devices – how lack of transparency inhibits improvement in evaluation”. The learning objectives are: Join us for free and register here

CORE-MD Webinar: Providing high-risk medical devices for children – problems and proposals

Indicative schedule : 18:00 – 18:05 Introduction by Moderator Prof. Alan Fraser, Cardiff University, CORE-MD Scientific Coordinator.18:05 – 18:15 Systematic Review of evidence for high-risk medical devices in Children | Kathrin Guerlich. Child Health Foundation (Stiftung Kindergesundheit), c/o Dr. von Hauner Children’s Hospital, Munich, Germany.18:15 – 18:25 Disappearing Orphan Devices | Em. Prof. Marc Gewillig, Association […]

CORE-MD webinar on 5 December 2023: IT Tool for for regulatory science: aggregating available data for post-market surveillance

Indicative schedule : 17:00-17:05 Introduction by Moderator Prof. Alan Fraser, Cardiff University, CORE-MD Scientific Coordinator 17:05 – 17:25 Exploiting IT tools to retrieve alerts and reports of high-risk medical devices – presenting the CORE-MD search engine, Prof. Enrico Caiani, Politecnico Di Milano 17:25 – 17:35 The EMA’s expert panels role in Surveillance Dr Miguel Antunes, EMA […]

A dedicated session on medical devices and the contribution of CORE-MD at the Biomedical Alliance General Assembly

On 24 November 2023, the Biomedical Alliance held its General Assembly gathering representatives from their 36 member scientific societies. In the framework of this meeting, a dedicated session, chaired by Prof. Elisabeth Mcintyre, Biomedical Alliance President elect, on real-world evidence and registries was organised to present the challenges of the implementation of the Medical Device […]

CORE-MD workshop on high-risk medical devices

The CORE-MD Project organised on 21st November 2023, at the BIOMED ALLIANCE new premises in Brussels, a workshop aiming to prepare a matrix of recommended methodologies for the clinical evaluation of high-risk medical devices. Among the 30 regulatory guidance documents, the 12 ISO Standards and the 4 documents from other Research Consortia, there are gaps that have been […]