Day 1 – Session

A session at 2-day In-person Seminar on “Implementing Risk Management Principles & Activities within Quality Management System” at Singapore

Thursday 27th February, 2014

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

Lecture 1: Introduction into Risk Management and Quality System Integration

Why risk management?
Historical perspective
International regulatory / statutory requirements
Risk Management Lifecycle and stakeholders
Over-reaching concept
Integration into ISO13486
Lifecycle steps
Risk Management Benefits
Liability issues
Streamlining product development
Improving product safety and quality
How I to implement Risk Management into ISO13486
SOP framework
Planning and execution
Monitoring and control
Tips and tricks

Lecture 2: Risk Management to ISO 14971:2012

Risk Management Planning
Risk Management Life Cycle
Hazard Identification
Hazard Domains
Hazard Latency Issues
Risk Rating Methods
Initial (unmitigated) Risk Assessment
Mitigation Strategies and Priorities
Mitigation Architectures
Alarm Systems as Mitigations
Risk Control Bundles
Post Mitigation Risk
Residual Risk
Safety Integrity Levels
European special requirements (Z-Annexes)
Safety Requirements
Hazard Mitigation Traceability
Verification Planning
Architectures, Redundancy and Diversity
Failure Mode and Effect Analysis / FTA
Verification Strategies
System Validation / Mitigation Validation

About the speaker

This person is speaking at this event.
Markus Weber

Principal Consultant, System Safety Inc.

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 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.

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Time 9:00am6:00pm SMT

Date Thu 27th February 2014

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