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Training Options  Duration: 60 Minutes   Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) Price: $295.00 Refund Policy

by Albert Cefalo 
Overview: Back 0n September 5th 2007 the European Union released directive 2007/47/EC (amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market). The implementation date for this Directive is currently set for March of 2010. This webinar will focus on the changes to the Medical Device Directive requirements that were introduced in the September 2007 Directive. Some of the highlights of the new requirements include additional requirements for Clinical Studies, software definitions, the relationship to the Machinery Directive, and many others. Attendees of this session will come away with a good understanding of what changes will be required for obtaining a CE Mark for their device(s) as well as the additions and changes which will be necessary for the Technical File associated with the device.

Areas Covered in the Session:

• New MDD Requirements
  
• Effective Date of 2007/47/EC
  
• Requirements for Clinical Studies
  
• Requirement for Software

Who Will Benefit:

• Design Engineers
  
• Quality Assurance Personnel
  
• Program Managers
  
• Manufacturing Engineers
  
• Regulatory Personnel
  
• Engineering Managers