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CE Marking: Obtaining and Maintaining EU Compliance Under the Medical Device Directive

 
  January 03, 2011  
     
 


ComplianceOnline, Online Event
2011-02-11


NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.  

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.

Areas Covered in the Seminar:

  • Device classification distinctions, and what that means to you in terms of compliance burden.
  • Technical File contents and organization.
  • Review and selection of your notified body.
  • How to show compliance with the Essential Requirements.
  • Changes to MDD and their implications.
  • What is expected for clinical data.

Who Will Benefit:

This webinar will provide valuable assistance to all device manufacturers who wish to sell product in the European Community. The employees who will benefit include:

  • Top management
  • Regulatory management
  • Quality Management
  • Sales and Marketing Management
  • Quality Engineers
  • Other personnel involved in development and implementation of the QMS
 
 
Organized by: ComplianceOnline
Invited Speakers: Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
 
Deadline for Abstracts: 2011-02-11
 
Registration:

Attend Live Online Training

$299.00 One Dial-in One Attendee

$1,199.00 Group–Max. 10 Attendees

 

 

E-mail: admin@complianceonline.com
 
   
 
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