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Medical Device Risk Management
An elective course in the Certificate Program in Medical Device Development.
Course closed to new registrations: Call ( 949 ) 824-5414 for more information or sign up below to be notified when this course becomes available.
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Course Description
Risk management integrated into the overall quality management is one of the main components for global medical device compliance. To meet the approval requirements for almost every regulated market a comprehensive implementation and documentation of a full risk management lifecycle has to be demonstrated. This course introduces the major components necessary to achieve global regulatory compliance and approvability. The main emphasis is on European and US regulation. A practical path to implanting a successful risk management system across different subsystems will be presented. The main issues covered are risk management, compliance with IEC60601-1, usability engineering and software risk management.
Prerequisite: EECS X445.2, Regulatory Requirements for Medical Devices, or equivalent experience.
Optional Text Resources:
ISO14971:2012 - Medical Devices – Application of RISK Management to Medical Devices
IEC 62304:2006 - MEDICAL DEVICE SOFTWARE – Software life cycle Processes
IEC 62366:2007 – Medical devices - Application of usability engineering to medical devices
FDA Guidance for the Content of Premarket Submission for Medical Device Containing SoftwareFDA-CDRH-CBER, Rockville, MD, 05/2005 (available at FDA website)
FDA Guidance - Applying Human Factors and Usability Engineering to Optimize Medical Device Design FDA-CDRH, Rockville, MD, 06/2011 (available at FDA website)
Instructor
Textbook Information
Textbooks for your course may be purchased from any vendor or bookseller of your choice.
No textbooks are required for this course.
Meeting Schedule
Event Date Day Start Time End Time Location Room
START 01/03/2023 Tuesday --- --- Online (Access Begins) ---
END 03/12/2023 Sunday --- --- Online (Access Ends) ---