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Sep 2013


DoubleTree by Hilton Hotel Philadelphia Center City 237 South Broad Street Philadelphia, , Pennsylvania 19107-5686
Tel: (215) 893-1600
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2-day In-person Seminar On "Applying ISO14971 And IEC62304 - A Guide To Practical Risk Management" At Philadelphia


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

Contact Information:
Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884





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