Thursday 23rd October, 2014
9:00am to 6:00pm
Lecture 1: Introduction into Risk Management and Quality System Integration
Why risk management?
Risk Management Lifecycle and stakeholders
Risk Management Benefits
How to Implement Risk Management into ISO13485
Tips and tricks
Principal Consultant, System Safety Inc.
Markus Weber is owner and Principal Consultant with System Safety, Inc. He 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 his consulting company, 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. Over the last 25 years Mr. Weber has helped hundreds of companies, from start-ups to Fortune 500 firms, to design safe medical devices. He trained hundreds of professionals on four continents in practical risk management and system safety methodologies. He frequently conducts webinars, in-person seminars, corporate training and he teaches Medical Device Risk Management the University of California Irvine Extension.
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