CE Marking: Obtaining and Maintaining EU Compliance Under the Medical Device Directive - ComplianceO (Medical Device)
Venue: Online Event
|Event Date/Time: Jun 10, 2011||End Date/Time: Jun 10, 2011|
Why You Should Attend:
Medical devices cannot be shipped to Europe unless they are in full compliance with the Medical Device Directive. The compliance burden is very different depending on the classification of the device.
This session will cover the Technical File and Essential Requirements document, in which design documentation must be maintained; unless you are intimately familiar with the requirements in advance, this could be a serious compliance issue. Also contained will be the recent changes to the MDD, noncompliance with which opens the possibility of cessation of certification. Also, unlike domestic (US) regulations, the MDD requires clinical data - methods for gathering this data will be reviewed. Notified body selection is a critical aspect of MD compliance - this webinar will share some tips and provide experience in this area.
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