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EU Medical Device Classification - Webinar By GlobalCompliancePanel

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EU Medical Device Classification - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                       


    RAPS Approved Webinar                  on
 
      EU Medical Device Classification

    Date & Time:                                                                                                                        

     Course "EU Medical Device Classification" has been pre-
     approved by RAPS as eligible for up to 1.00 credits towards a
                                                                                                  Register Now                          

     participant's RAC recertification upon full completion.


                                                                                             Instructor Profile:
     Wednesday, September 12,
                                          10:00 AM PDT | 01:00 PM EDT
     2012
                                                                                                           Joy Frestedt
     Duration: 60 Minutes                 Instructor: Joy Frestedt                                  President and CEO, Frestedt
                                                                                                           Incorporated
     Location: Online                     Price : $245.00   (for one participant)


                                                                                             Joy Frestedt, PhD, CCTI, RAC,
                                                                                             FRAPS. Dr. Frestedt is the President
     Overview:
                                                                                             and CEO of Frestedt Incorporated, a
    It is not economically feasible to subject all medical devices to                        novel virtual Contract Research
    rigorous conformity assessment procedures. A more appropriate                            Organization network of over 50
    graduate system is now available that manufacturers should be able                       experts and highly skilled staff
    to determine the classification of their product early in the                            meeting specific needs in regulatory,
                                                                                             clinical and quality affairs. Dr.
    development stage. This medical device classification webinar will
                                                                                             Frestedt has over 30 years of
    review the risk based approach of the EU classification system. This
                                                                                             scientific, clinical and regulatory
    webinar will review two documents on this topic including the                            experience in the health care,
    "Medical Devices: Guidance Document - Classification of Medical                          pharmaceutical and medical device
    Devices" and "EU Council Directive 93/42/EC (as amended) - Annex                         industries especially running clinical
    IX Classification Criteria" which is applicable on the classification                    trials, conducting laboratory
    rules for medical devices which intend to ensure a high level of                         analyses and assisting firms with
    human health and safety.                                                                 strategic decisions involving clinical
                                                                                             research programs, regulatory
                                                                                             strategies and the development of
     Why Should You Attend:                                                                  quality systems to compete globally.
                                                                                             She has held key positions including
    Today, medical devices occupy an extensive range of products that
                                                                                             vice president of scientific,
    vary in intricacy and application. As the global market for medical
                                                                                             regulatory and clinical affairs at
    devices continues to grow, it is important that companies be                             BridgePoint Medical and Humanetics
    informed on the rules for classification of medical devices because of                   Corporation as well as key
    potential risk that can be associated with the device can have on the                    management positions with Johnson
    human body when used. This webinar will discuss the application of                       and Johnson’s Ortho Biotech,
    EU Council Directive on medical device classification.                                   Medtronic, Mayo Clinical Trial
                                                                                             Services, AstraZenca
                                                                                             Pharmaceuticals and Orphan
     Areas Covered in the Session:                                                           Medical. Dr. Frestedt holds a B.A. in
                                                                                             biology from Knox College and a
                                                                                             Ph.D. in pathobiology from the
        l   Basic definitions and purpose of medical device classification
                                                                                             University of Minnesota Medical
        l   How to carry out classification by reviewing the application and                 School and she is a member of the
            how to use the classification rules                                              American Society of Clinical
        l   Explanation of individual classification rules regarding non-                    Oncologists, American Association of
            invasive and invasive devises, along with additional rules                       Pharmaceutical Scientists, ...more
            applicable to active devices and other special rules


    Click here to register for this webinar                                                 Suggest a Topic       More Webinars

                                                                                              Your Necessity is our Priority
     Who Will Benefit:

        l   Quality Managers and Professionals
        l   Marketing Managers and Professionals
        l   Risk Managers and Investigators                                                                    
        l   R&D Project Managers and Team Members
        l   Design Engineers
        l   Consultants



It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel



About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.


GlobalCompliancePanel
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801

Phone: 800-447-9407 or
Fax your PO to: 302-288-6884


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DOCUMENT INFO
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posted:8/10/2012
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Description: Overview: It is not economically feasible to subject all medical devices to rigorous conformity assessment procedures. A more appropriate graduate system is now available that manufacturers should be able to determine the classification of their product early in the development stage. This medical device classification webinar will review the risk based approach of the EU classification system. This webinar will review two documents on this topic including the "Medical Devices: Guidance Document - Classification of Medical Devices" and "EU Council Directive 93/42/EC (as amended) - Annex IX Classification Criteria" which is applicable on the classification rules for medical devices which intend to ensure a high level of human health and safety.