Seminar on
Risk Management in Medical Devices Industry
Date & Time: April 12th and April 13th 2012
9 AM PDT to 5 PM PDT
Duration: 2 Days
Instructor: Markus Weber
Location: Boston
Price : $1695.00
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Instructor Profile: Markus Weber Principal Consultant, System Safety Inc.
Overview: The course will introduce the main elements of risk management and the application of risk management principles and requirements to the medical device development cycle. Risk management has become
Markus Weber, 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 softwarecontrolled 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. ...more
the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management as a mandatory component of almost any activity in the medical device industry. The course will emphasise the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management a s well as the increasingly important software related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden.
Areas Covered in the Session: Day 1, April 12, 2012 Lecture 1: l l l l l l l l
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Risk management planning Risk management life cycle
Your Necessity is our Priority
Hazard identification Hazard domains Hazard latency issues Risk rating methods
Initial (unmitigated) risk assessment Q&A Session
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Mitigation strategies and priorities Mitigation architectures Alarm systems as mitigations Risk control bundles Post mitigation risk Residual risk Safety Integrity levels Q&A Session
Day 2, April 13, 2012 Lecture 3: l l l l
Usability as hazard source and mitigation Safety requirements Hazard mitigation traceability Verification planning
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Architectures, redundancy and diversity Failure mode and effect analysis / FTA Verification strategies System validation / mitigation validation
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Q&A Session
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Lecture 4: l l l l l l l l l l l
Critical software issues Software hazard mitigation strategies Software item, unit and system definition Software failures as hazard sources Software requirements and design specification Software tools and development environment Software unit and integration testing Real-time system challenges Software verification and validation Mitigation traceability and effectiveness Q&A Session
Click here to register for this webinar Who Will Benefit: l l l l l l
Project Managers Regulatory / Compliance Managers and Specialists Quality Assurance Managers System Engineering Hardware Engineers Software Engineers
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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