Medical Devices 2011 - Emerging FDA and EU Trends in IVD Regulatory Compliance

This 3-hr training on FDA and EU Trends in IVD Regulatory Compliance will review current strategic issues and tactical points to consider relating to legal, regulatory and product development practices in the US and EU for In Vitro Diagnostic products.

Significant changes in statutory, regulatory and Agency policies relating to medical devices, generally and in vitro diagnostic products in particular are currently underway.

This interactive virtual seminar will cut through the legislative and regulatory clutter, the jargon being used and array of policy changes for IVD products. Webinar participants will gain a solid understanding of the broad initiatives as well as the key regulatory issues and policies that will shape IVD device registration and compliance for the foreseeable future. Emphasis will be placed on detailed requirements and practical strategic options that regulatory, quality and development professionals will need to avoid costly problems in bringing new IVD products to market in the next three to five years.