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Medical Device Risk Management

An elective course in the Certificate Program in Medical Device Development.

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:

  1. ISO14971:2012 - Medical Devices – Application of RISK Management to Medical Devices
  2. IEC 62304:2006 - MEDICAL DEVICE SOFTWARE – Software life cycle Processes
  3. IEC 62366:2007 – Medical devices - Application of usability engineering to medical devices
  4. FDA Guidance for the Content of Premarket Submission for Medical Device Containing SoftwareFDA-CDRH-CBER, Rockville, MD, 05/2005 (available at  FDA website)
  5. FDA Guidance - Applying Human Factors and Usability Engineering to Optimize Medical Device Design FDA-CDRH, Rockville, MD, 06/2011 (available at  FDA website)

  • Details
  • $735
  • January 10, 2022 to March 20, 2022
  • Delivery Mode: Online
  • Reg#: 00161
  • ID/Units: BME X406  (3.00)
    ( Section 1 )
  • Quarter: WINTER 2022

Instructor


Markus Weber, M.S.E.E., 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 software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

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

EventDateDayStart TimeEnd TimeLocationRoom
START01/10/2022Monday------Online (Access Begins)---
END03/20/2022Sunday------Online (Access Ends)---