Risk Management System in Medical Devices Industry
Principal Consultant, System Safety, Inc
Principal Consultant, System Safety, Inc
Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.
Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations.
By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.
This course is relevant to managers, supervisors, QA / RA, and design/system engineers. Even experienced personnel will benefit from the "across industry" perspective and the illustration of standard practices that only a presenter with extensive experience in more than 100 projects can provide. Specific positions that would benefit are:
Software Risk Management (IEC62304 / FDA Software Reviewers' Guidance)
Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. Mr. Weber 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, he 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. He has helped multiple companies, from startups to Fortune 500 firms.
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