Clinical Evaluation of Medical Devices

The event titled Clinical Evaluation of Medical Devices is hosted by TOPRA - The Organisation for Professionals in Regulatory Affairs, located in London, United Kingdom. This course is specifically designed for various professionals including students of the TOPRA MSc program, delegates from the healthcare regulatory affairs profession, individuals from allied industries, and clinical trial experts seeking to deepen their knowledge concerning the clinical evaluation of medical devices. It offers a comprehensive understanding of the regulatory frameworks, methodologies, and strategic roles associated with clinical evaluation throughout the device lifecycle. Participants will gain critical insights into global regulatory frameworks, directives, and documentation pertinent to clinical evaluation. The course aims to enhance attendees' ability to evaluate clinical research methodology, assess the quality and relevance of existing evidence, and analyze legal and technical documentation that supports clinical evaluations. Furthermore, it addresses the systematic and creative approach to complex issues, ensuring that participants can communicate their conclusions clearly to both specialist and non-specialist audiences. Key topics covered in the masterclass include the transition from EU MDD 93/42 to EU MDR 2017/745, roles and responsibilities in conducting clinical evaluations, clinical evaluations for marketed devices, and the role of clinical evaluations within technical documentation and the device lifecycle. Other essential subjects include equivalence assessments under the MDR, clinical investigations, and global clinical strategy requirements with a focus on the U.S. This course is a valuable opportunity for those involved in the medical device sector to enhance their understanding of regulatory affairs and clinical evaluation processes.