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Conference Details
Risk Management Standard in Medical Devices Seminar 2018
Date :
Place : United States, Denver
Contact Person:John Robinson
Description:
Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software. To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.Risk Management Standard in Medical Devices Seminar 2018 will be held in Denver,United States on date 2018-05-04
Deadline for abstracts/proposals : 1st May 2018
Organized By :NetZealous LLC DBA GlobalCompliancePanel
Keynote Speakers : Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and so
Conference Highlights :Course "Risk Management in Medical Devices Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementatio
Venue :Denver, CO, USA
Check the event website for more details.
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