After a few quiet years, several important European regulatory changes have occurred that will affect most medical device manufacturers. Most notably, Competent Authorities are now expecting manufacturers to have a good understanding of post-market surveillance, including vigilance. Notified Bodies and Competent Authorities alike are starting to make this a key element of their inspections and companies must be prepared.

In this presentation, Dr. Loh discusses important new revisions to MEDDEV 2.12-1 rev 5, Guidelines on a medical devices vigilance system, published in April 2007. The guidelines entered into force on January 1st, 2008.

This audio conference covers:

• Differences between revision 4 (2001) and revision 5 (2007)
• Adverse event reporting requirements
• Field safety corrective actions
• New items: periodic summary reporting and trend reporting
• New "event" reporting requirements
• What constitutes "user error" and "abnormal use"

About the speaker:

Dr. Evangeline Loh oversees regulatory consulting support for Emergo clients worldwide, and oversees Emergo's 400 plus Authorized Representative clients. Prior to joining Emergo Group, Dr. Loh was involved in regulatory affairs for the surgery and critical care units of Cook, Inc. She has extensive knowledge of US and EU regulations, in addition to working on regulatory submissions around the world. Prior to her tenure at Cook, Dr. Loh worked for the Division of Biomedical Sciences at the Association of American Medical Colleges (AAMC) in Washington, DC. Her role there was to develop data metrics and quality control measures, conduct statistical analysis to evaluate the performance of clinical sites, and to manage graduate education policy.

As a graduate student at the University of Texas Health Science Center at San Antonio, Dr. Loh designed and implemented research protocols to conduct experimental research using complex molecular techniques. She obtained a BS in Microbiology from Cornell University, a PhD in Pharmacology from the University of Texas Health Science Center at San Antonio, and holds the RAC (US, EU) designation from the Regulatory Affairs Professional Society.

Who should attend?

• Senior Management
• Regulatory Affairs
• Quality Assurance
• Sales and Marketing

This audio conference is rated General Interest.