The 510(k) Process and Risk Management - Webinar By ComplianceOnline (Medical Devices Trai)
Venue: Online Event
|Event Date/Time: Apr 15, 2011||End Date/Time: Apr 15, 2011|
The majority of medical devices being placed on the US market are cleared through the Premarket Notification or 510(k) process. Recently FDA has indicated it is tightening this process after some controversy surrounding devices cleared for market. This controversy resulted in replacement of the Director of the Center of Devices and Radiological Devices. An internal report identified some issues and called for an external review of the process, which the FDA commissioned. Manufacturers need to prepare for the impact to product clearance for the US market.
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