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.
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. 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