The Changes to CE Certification of Medical Devices starting in 2014
12 Nov 2013, 09:00
12 Nov 2013, 16:00
The objective of this one hour complimentary webinar (45-minute presentation / 15-minute Q&A) is to 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
Changes to Technical Documentation and Technical File Assessments
Changes for Notified Bodies
Changes to Contracts
Priority Actions for Manufacturers
Mr. Chris Jepson BSc., FCQI, MIMMM, C Eng SGS Global Manager- Medical Devices
Mr. Jepson manages the SGS global medical devices activities and is currently Chair of NB MED, the forum of Medical Device Notified Bodies, Industry, EC Commission and other interested parties. In this role he is involved with the ongoing European discussions on changes to current Notified Body policy and the future revisions to the medical device directives. He is a chartered materials engineer and fellow of the Chartered Quality Institute.
Tuesday, 12 November 2013 9:00 a.m. London (GMT Summer Time)
Tuesday, 12 November 2013 15:00 p.m. London (GMT Summer Time)