FDAs 2011 Revised 510(k) Premarket Notification Process (Medical Devices Trai)
Venue: Online Event
|Event Date/Time: Apr 08, 2011||End Date/Time: Apr 08, 2011|
FDA is poised to initiate substantial changes to the Premarket Notification â€œ510(k)â€ 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 Projectâ€™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 productâ€™s likelihood of clearing the evolving regulatory hurdles.
Do you have the knowledge, skills and tools necessary to lead your team to marketing clearance or approval? Do your current strategies address national (U.S. FDA) and international regulatory requirements (EU, Canada, etc) ensure a lean and FDA-compliant engineering, quality, clinical and regulatory practices are employed?
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