This complimentary webinar will explain the changes in auditing and technical file assessments for medical devices which will be starting in 2014. It will outline the main changes in the two EU Commission documents published on September 24 and help manufacturers plan their compliance and management of new features such as unannounced audits.


  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 for Session 1
05:00 p.m. Singapore, Kuala Lumpur (Singapore Time)
09:00 a.m. London (GMT Summer Time)
10:00 a.m. Paris, Berlin, Madrid, Amsterdam (Europe Summer Time)

Click here to register for Session 2
10:00 a.m. New York (Eastern Daylight Time)
03:00 p.m. London (GMT Summer Time)
04:00 p.m. Paris, Berlin, Madrid, Amsterdam (Europe 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.

For more information, please contact:

Outi Armstrong
1 Place des Alpes
1211 Geneva
t: +41 22 739 9161

Language: English

Cost: No Charge

Event location: Online