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Audio conference highlights

In September 2007, the long-anticipated revisions to the Medical Devices Directive (MDD 93/42/EEC) were published in Directive 2007/47/EC, which becomes mandatory in 2010. There are more definitions, software is a device, there is clarification on combination products, single-use devices, and reprocessing, administrative modifications, closer inspection of design documentation required by the Notified Body, outsourced design and manufacturing need to be more closely monitored, classification changes, IFUs must be revision controlled, records retained for five years, and emphasis on clinical data, including Class I devices. This presentation highlights the modifications to the directive, and what they mean for device companies.

This audio conference covers:

• New requirements for medical devices
• Expectations for clinical data, including Class I
• New definition entries in Article 1 and Annex IX, Classification Criteria
• Added requirements to Essential Requirements Checklist, Annex I
• Clarification regarding Notified Body inspection of Design Documentation?

Dr. Evangeline Loh oversees regulatory consulting support for Emergo clients worldwide, and oversees Emergo's European 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

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.