We use cookies to personalise content and ads, to provide social media features and to analyse our traffic. We may also share information about your use of our site with our social media, advertising and analytics partners. Read more about our Privacy Policy.

I got it!

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

When

8 May 2013 @ 10:00 am

8 May 2013 @ 11:00 am

Duration: 1 hours

Timezone: GMT -8:00


Where

Online Webinar


Organised by

GlobalCompliancePanel (deactivated)

Other Events in Health

Similar Webinars in Health

Recent Publications in Health

Recent Videos in Health

Recent Speakers in Health

Paul R. Hales
Speaker

8

Joseph R. Batte
Speaker

1

Casper Uldriks
Speaker

17

Recent News in Health

Important meeting with @CancerLeagues to discuss the close links between #EUPharmaStrategy and #EUCancerPlan. Toget… https://t.co/wLklyzJ29z

@EU_Health - 15 Jan 2021 19:57

Media briefing on #COVID19 with @DrTedros https://t.co/wzF4kbuA2B

@WHO_Europe - 15 Jan 2021 18:39

Latest @ECDC_EU #CDTR report is out now! This week's issue includes updates on: ➡️ #Lyssavirus infection ➡️… https://t.co/IWEsCtGLnQ

@ECDC_EU - 15 Jan 2021 16:17