FREE WEBINAR: Evolutions in the EU IVD Regulatory Framework
Wednesday, April 16, 2014 from 2:00 PM to 3:00 PM (EDT)
The EU in vitro diagnostic medical device regulatory landscape is changing drastically. The changes of the IVD Medical Device Directive 98/79/EC (IVDD) are expecting to lead to a fully remodeled regulation impacting:
For information on the new requirements so far and the changes that could be coming, manufacturers can tune to LNE/G-MED North America’s upcoming Free webinar, Evolutions in the EU IVD Regulatory Framework, on April 16th at 2:00 PM Eastern.
This webinar will cover the major changes that we see coming in the new IVD regulatory framework, as well as a notified body’s perspective on what these changes mean for an IVD manufacturer.
Come join us on April 16th at 2:00 PM (Eastern Time) to hear how these changes may affect you and your products
LNE/G-MED America, Inc. is the North American subsidiary of the National Metrology and Testing Laboratory, LNE, the leading French notified body established in 1901. We serve the medical device industry with offices on the East and West Coasts of the United States. LNE/GMED is one of the Leading European Notified Bodies in North America and a single-source provider of Voluntary and Regulatory certifications.
Our goal: Provide the best in product certification and quality management certification services for manufacturers worldwide. In addition to our CE marking, ISO 9001, and ISO 13485 CMDCAS certification services, LNE/G-MED has a long tradition in providing testing services such as EMC and electrical safety testing for any of the European medical device standards. Manufactures of medical devices reach out to LNE/G-MED in seeking access to European, Canadian, Asian, and other regulated markets. Our full range of technical conformity services, from diagnostic audits to training, allows the convenience and efficiency of a US-based team of technical experts, auditors and program managers and make us one of the leading European Notified Bodies in North America.
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