Applying ISO14971 and IEC62304 - A guide to practical Risk Management

Overview:
This seminar covers the compliance issues relating to ISO 14971, IEC 62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate activities to cover all three requirements documents is presented.

Course Description:

Day 1 – Agenda
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 – Agenda
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

About Speaker:
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.

Date, Venue and Price:
Location: Philadelphia | November 7th & 8th, 2013 | 9 AM to 6 PM EDT
Venue: DoubleTree by Hilton Hotel Philadelphia Center City
Address: 237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA
Price: $1,295.00

Discount for One Delegate and Group Participants:
Register now and save $200. (Early Bird)
Until September 15, Early Bird Price: $1,295.00
From September 16 to November 05, Regular Price: $1,495.00

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