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Medical Device Design Control

Medical Device Design Control - Webinar By GlobalCompliancePanel

Overview: Understanding, interpreting, and implementing design control requirements in a holistic manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment. In this presentation, you will get familiar with regulatory and quality requirements of design control concerning medical devices, active implantable medical devices and IVDs.This webinar will greatly help medical device industry and relevant professionals establish and maintain adequate design control procedures.Why Should You Attend: Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs.Areas Covered in the Session:Federal Statutes and Regulations Governing Medical Devices in the USIntroduction and DefinitionsDesign and Development PlanningDesign InputDesign OutputDesign ReviewDesign Verification And Validation including Software ValidationDesign TransferDesign ChangesDesign History File (DHF)Device History Record (DHR) and Device Master Record (DMR)Who Will Benefit:R&D Scientists, Engineers, Managers, and DirectorsRegulatory AffairsQuality ProfessionalsProduct Development ProfessionalsCROsConsultantsSenior ManagementContractors and SubcontractorsAnyone interested in design controlDr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company.Price: $225.00GlobalCompliancePanelUSA Phone:800-447-9407Fax: 302-288-6884


8 May 2013 @ 10:00 am

8 May 2013 @ 11:00 am

Duration: 1 hours

Timezone: GMT -8:00


Online Webinar

Organised by

GlobalCompliancePanel (deactivated)

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