The EU IVDR will profoundly affect the diagnostics market in Europe. A new risk-based classification system, stricter postmarket surveillance, upgraded dossiers for all products and notified body review of most previously self-declared products, greater clinical evidence requirements, and novel emphasis on transparency and traceability, including reporting of risk, clinical, safety, and performance data to a publicly available database, will require massive investments of time and money as well as significant changes in organizational structure. The transition period may seem long, but consultants and the dwindling number of notified bodies are already swamped with EU MDR implementation. Help will be hard to find. Planning should start now.

The regulations are there for anyone to read, but even the largest, best-prepared companies have teams struggling with interpretation and implementation. By pooling thoughts and approaches we can expedite the process for everyone. This two-day workshop convenes experts from major companies, notified bodies, and consulting firms to share strategies and procedures.

EU MDR the Cost of Compliance: Assessing Infrastructure and Resource Impact

March 5 – 6, 2019
Washington, DC & Virtual

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EU MDR Clinical & Postmarket Surveillance Strategies

March 6 – 7, 2019
Washington, DC & Virtual

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EU IVDR Implementation

April 11 - 12, 2019
Washington, DC & Virtual

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EU MDR Supply Chain & Economic Operators

April 16 - 17, 2019
Washington, DC & Virtual

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EU MDR Labeling, IFU, UDI, & Eudamed

May 23 - 24, 2019
Washington, DC & Virtual

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Pricing

We offer Team, Enterprise and multi-conference Discounts.
Veronica Allen, Conference Manager can help you select the right discount plan for you and your organization.

Register Today!

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