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Day 2 – Session

A session at 2-day In-person Seminar on “Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management” in Berlin, Germany

Thursday 23rd October, 2014

9:00am to 6:00pm (CET)

Lecture 3: Usability and Risk Management
Lecture 4: Software Risk Management (IEC62304 / FDA software reviewers' guidance)
Lecture 5: Software Risk Management (IEC62304 / FDA software reviewers' guidance)
Lecture 6: Safety / Assurance case

About the speaker

This person is speaking at this event.
Markus Weber

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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When

Time 9:00am6:00pm CET

Date Thu 23rd October 2014

Short URL

lanyrd.com/sddfqt

Official session page

bit.ly/XzsbJC

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