Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005 Compliance - Webinar By GlobalCompliancePanel October 4, 2012

Overview: This seminar covers the compliance issues relating to ISO14971, IEC62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate activities to cover all three requirements documents is presented.

Detailed Agenda:

Day 1, Oct 04th, 2012

Lecture 1 (ISO 14971):
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
Lecture 2 (ISO 14971):
Alarm Systems as Mitigations
Risk Control Bundles
Post Mitigation Risk
Residual Risk
Safety Integrity Levels
Usability as Hazard Source and Mitigation
Safety Requirements
Hazard Mitigation Traceability
Verification Planning
Architectures, Redundancy and Diversity
Failure Mode and Effect Analysis / FTA
Verification Strategies
System Validation / Mitigation Validation
Day 2, Oct 05th, 2012

Lecture 3 (IEC60601-1:2005):
References to Risk Management
Section 4 Risk Related Issues
Compliance for Non-Software Related Issues
The IEC TRF (technical report form)
Special PEMS Issues
PEMS and IEC62304
Lecture 4 (IEC62304):
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
Who will benefit:
Project Managers
Regulatory / Compliance Managers and Specialists
Quality Assurance Managers
System Engineering
Hardware Engineers
Software Engineers

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.

Official Website: http://bit.ly/NHolbe