European Union Changes in Medical Device Regulations, Miami, USA
26-27 April 2018
The Society of Clinical Research Associates (SOCRA) is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. The SOCRA 12th Annual Device Research & Regulatory Conference is being held at the Miami Beach Resort on 26-27 April 2018, during which will be discussed current issues relating to compliance, development, and medical device clinical research. A half-day optional Device Basics workshop precedes the main conference.
The second day of the conference includes a presentation from DLC's President, Maria E. Donawa, M.D. on the subject of 'European Union Changes in Medical Device Regulations'. The EU has introduced sweeping new regulations for medical devices, including in vitro diagnostic devices, which will become mandatory in 2020 and 2022, respectively. Given the extent of the changes, this is not a great deal of time for all involved parties to be ready for compliance. This session will provide an overview of these regulations and highlight the new requirements that will represent the most significant challenges for compliance.
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