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This webinar will explain the changes to CE certification of medical devices that will be effective in 2014, including changes to audits and quality management systems and changes to technical documentation and technical file assessments.


November 13, 2013


November 13, 2013




  1. Introduction and Background
  2. Changes to Audits and Quality Management Systems
  3. Unannounced Audits
  4. Changes to Technical Documentation and Technical File Assessments
  5. Changes for Notified Bodies
  6. Changes to Contracts
  7. Priority Actions for Manufacturers

Target Audience

Medical device manufacturers and organizations who have certification under one of the European medical device directives (Active Implantable Medical Devices, 93/42/EEC Medical devices and 98/79/EC In Vitro Diagnostic Medical Devices) or who plan to obtain such certification. Those people involved with or responsible for quality systems, regulatory affairs, product design, manufacture or clinical activities will find the subject relevant.

Click here to register 
09:00 a.m. San Francisco (Pacific Daylight Time)
11:00 a.m. Chicago (Central Daylight Time)
12:00 p.m. New York (Eastern Daylight Time)
05:00 p.m. London (GMT Summer Time)

After registration, you will also receive the link to the updated white paper containing the new regulations for Notified Bodies published by the European Commission in September 2013.

*This webinar will be recorded and made available 24-48 hours after the live event.

Language: English
Cost: No Charge 

For more information, please contact:

Nelirene Dablio
Global Interactive Marketing Manager
t: +63 2 848 0777 loc. 8772