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The New MDD: 14 Things You Need to Know
Dr. Evangeline Loh
Director of Regulatory Affairs
Emergo
Group Inc.
Recording
- US$249
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In
late September, 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 will highlight the
modifications to the directive, and what they mean for device
companies.
This audio
conference will address:
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New
requirements for medical devices
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Expectations for clinical data, including Class I
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New
definition entries in Article 1 and Annex IX, Classification
Criteria
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Added requirements to Essential Requirements Checklist, Annex
I
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Clarification regarding Notified Body inspection of Design
Documentation
Speaker
biography:
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
This
audio conference is rated General Interest.
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