ComplianceOnline, Online Event
2012-09-13
Why Should You Attend: Medical devices declared compliant must bear a CE mark in order to be admitted into the 29 member countries comprising the EU. The market population of these 29 countries is 450 million people, exceeding the 420 million people served by NAFTA (USA, Canada & Mexico), so many companies have an interest in penetrating this market. This presentation will provide an explanation in layman’s terms of the various routes to CE marking of medical devices, with a focus on the Medical Device Directive, MDD 93/42/EEC. Areas Covered in the seminar: - New approach directives & background
- IVD, MDD & Active Implantable Directive
- Competent Authorities & Notified Bodies
- Medical Device Directive
- Device classification
- Routes to CE marking under various MDD annexes
- Technical files
- Essential requirements
- ISO 13485:2003 Quality System Certification
Event Details: Date: September 13, 2012 Time: 10:00 AM-11:00 AM PDT Cost: $249 per attendee per computer terminal Registration: SIgn-Up on-line now. Add to your shopping cart. |
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