Getting to Market in the EU: Making sense of the many EU requirements for Clinical Data
May 08, 2012, Webinar (12:00 - 1:00 pm Eastern Time)
With the recent medical devices scandals in the EU, the Commissioner has publically requested tighter controls. Clinical evaluations are an area that have come under scrutiny in recent years, resulting in multiple changes in the regulations and standards, creating additional potential consequences for manufacturers who are selling legacy devices or planning to introduce new models in the EU. Having a clear understanding of the requirement is crucial to certification and market entry. And due to recent changes in both standards and directives, manufacturers have more challenging requirements for the evaluation of clinical performance and effectiveness. Device manufacturers need to know what the new requirements are and how it may affect existing and new product certifications. In this live webinar, participants will have the opportunity to hear from the expert presenter, Dr. Dannhorn on strategies for meeting the new requirements and have the opportunity to ask questions.
Dr. Dieter R. Dannhorn is General Manager of the GLP certified test house and CRO "mdt medical device testing GmbH" (MDT) and of the consulting company "md registration support Limited"(MDRS), both part of the UL family of companies. After his university training as a biologist, he worked for two international pharmaceutical companies before he took over the management position at ‘mdt’ in 1996 and founded the consulting company ‘mdrs’ in 2005, and served as CEO and president of both companies.
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