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2day Inperson Seminar on Applying ISO14971 and IEC62304 A guide to practical Risk Management

11/7/2013 9:00 AM - 11/8/2013 6:00 PM

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

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884




NetZealous LLC

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

For More Info Click Here:

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