The Changes to CE Certification of Medical Devices starting in 2014

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.

Agenda

• 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

Presenter

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.

Morning Registration Link

Tuesday, 12 November 2013 9:00 a.m. London (GMT Summer Time)

Afternoon Registration Link

Tuesday, 12 November 2013 15:00 p.m.  London (GMT Summer Time)