|When:||« Back to Calendar January 18, 2018 @ 12:00 pm - 1:00 pm|
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The European Medical Device Regulation (MDR; EU 2017/745), which becomes mandatory on 26 May 2020 (date of application), introduces requirements on clinical evaluation that were previously only in European guidance. Compliance with these requirements will have a direct effect on the CE marking process and the ability of companies to avoid future disruption of their devices being maintained or placed on the European market. This webinar will provide an overview of clinical evaluation requirements, emphasizing those requirements likely to have the most significant impact on small, medium and large medical device companies. A brief update on European-level activities needed for implementation of the MDR will also be provided.
Maria E. Donawa, MD is President, Donawa Lifescience Consulting Srl, headquartered in Rome, Italy. Dr Donawa has over 30 years’ regulatory experience including six years with the US Food and Drug Administration in the area of medical device regulation. In 1986, after moving to Rome, Italy, she founded a consultancy company which has become Donawa Donawa Lifescience Consulting (DLC), which provides US and European quality system, regulatory and clinical (full CRO) services to life science companies worldwide. Dr Donawa is a member of the European Clinical Investigation and Evaluation Committee and active member of ISO TC 194, Working Group 4, responsible for development and revision of ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical practices.
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