GlobalCompliancePanel to organize RAPS pre-approved webinar on "EU Medical Device Classification"

(prHWY.com) August 24, 2012 - Wilmington, DE -- Description:
As the demand for medical devices expands and national borders become more and more liberalized; medical devices are set to cross national boundaries more easily. They will be made in one place and consumed in another. Rules and classifications for medical device specifications vary from one place to another. In this scenario, professionals in this industry need to know the regulations and intricacies of the product they manufacture and/or market.
It is not possible to physically put each and every medical device to conformity assessment procedures. As an easy way out, manufacturers should be able to classify their products from the early development stage itself. When this classification criterion is built into the elementary stages of the medical device manufacture; it becomes easier for them to avoid confusion and ensure better safety.
This webinar will review two important documents on medical device classification: "Medical Devices: Guidance Document - Classification of Medical Devices" and "EU Council Directive 93/42/EC (as amended) - Annex IX Classification Criteria". It will discuss the application of EU Council Directive on medical device classification. It covers the following areas:
o Basic definitions and purpose of medical device classification
o How to carry out classification by reviewing the application and how to use the classification rules
o Explanation of individual classification rules regarding non- invasive and invasive devises, along with additional rules applicable to active devices and other special rules.
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When: September 12, 10:00 AM PDT | 01:00 PM EDT
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By whom:Joy Frestedt, PhD, CCTI, RAC, FRAPS, is the President and CEO of Frestedt Incorporated, a novel virtual Contract Research Organization network of over 50 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs.
Dr. Frestedt has over 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries especially running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally.
Dr. Frestedt holds a B.A. in biology from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School. She was named one of the "100 Most Inspiring People in the Life Sciences Industry (by PharmaVOICE, 2011) and one of the top 25 "Industry Leaders/ Women in Business Award (by the Minneapolis/St. Paul Business Journal, 2011).
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For whom:
The webinar will benefit
o Quality Managers and Professionals
o Marketing Managers and Professionals
o Risk Managers and Investigators
o R&D Project Managers and Team Members
o Design Engineers
o Consultants
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Duration: 60 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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