All medical devices need clinical evidence in order to be lawfully and successfully marketed. Identifying the best methodology for building this evidence, however, depends on several factors, including the device’s intended purpose and patient population, the stage it is at within its lifecycle, and its underlying technology.
Starting from the premise that “the clinical objective drives the clinical evidence need,” this workshop explores the different clinical methodologies applied to medical devices as compared to medicines, both before and after the device is first marketed.
Participants will learn about and debate the central role of physicians/users in clinical studies, the merits and limitations of open label trials, comparative trials and randomized controlled trials (RCTs), and the best practices in how to leverage the power of registries and ‘Big Data’. Presenters will include key stakeholders including regulators, Notified Bodies, reimbursement experts, patient organization representatives and industry members.
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Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.
Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.
