FDA Compliance 2011 - The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions & Regulatory Compliance

Why Should You Attend:

FDA is poised to initiate substantial changes to the Premarket Notification “510(k)” process that will significantly increase the data and documentation requirements for Class II medical devices. Very few manufacturers are aware of the practical changes that will be needed during design control and 510(k) submission process to ensure lengthy and expensive delays do not occur for their new products.

As a Project’s Regulatory Leader, Quality Assurance Manager or Principal Design Engineer, what you do to craft a strategy will have profound ramifications for the company in terms of profitability, not to mention the product’s likelihood of clearing the evolving regulatory hurdles.

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