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.
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Among the 30 regulatory guidance documents, the 12 ISO Standards and the 4 documents from other Research Consortia, there are gaps that have been identified.
Several publications are already available on the CORE-MD Project website that provide a solid background evidence that such a matrix is needed.
The outcome of this workshop will be shared during a webinar. Check our website to see the full webinar calendar.