Webinar: The Changes to CE Certification of Medical Devices Starting in 2014

MessageThis Webinar is over
Date Nov 12, 2013
Time 11:00 AM EDT
Cost Free
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.


Introduction and Background
Changes to Audits and Quality Management Systems
Unannounced Audits
Changes to Technical Documentation and Technical File Assessments
Changes for Notified Bodies
Changes to Contracts
Priority Actions for Manufacturers


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.


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