2-day In-person Seminar on Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005 Compliance at San Diego by globalcompliancepane


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    2-day In-person Seminar on
     Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005

     Course "Risk Management: ISO14971, IEC62304 and
     IEC60601-1: 2005 Compliance" has been pre-approved by
                                                                                             Register Now                         
     RAPS as eligible for up to 12 credits towards a participant's
     RAC recertification upon full completion.

    Date & Time:                                                                        Instructor Profile:

     October 04th and 05th 2012           8 AM to 5 PM EDT
                                                                                                      Markus Weber
     Duration: 2 Days                     Instructor: Markus Weber                             Principal Consultant, System
                                                                                                         Safety Inc.
                                          Price : $1295.00   (for one
     Location: San Diego
                                                                                        Markus Weber, Principal
             Register for 4 Participants to Get 1 Free Pass                             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
    This seminar covers the compliance issues relating to ISO14971,                     a MS in Electrical Engineering.
    IEC62304 and IEC60601-1:2005. Especially the cross-standard and                     Before founding System Safety, Inc.,
    practical means to integrate activities to cover all three requirements             he was a software safety engineer
    documents is presented.                                                             for the German approval agency,
                                                                                        TUV. Since 1991, Mr. Weber has
                                                                                        been a leading consultant to the
    Course Outline:                                                                     medical device industry on safety
                                                                                        and regulatory compliance issues,
                                                                                        specifically for active and software-
    Course Outline: Day 1:
                                                                                        controlled devices. In conjunction
                                                                                        with the FDA, he has published
    Lecture 1: (ISO 14971):                                                             works on risk management issues
                                                                                        and software-related risk
       l   Risk Management Planning                                                     mitigations. Mr. Weber has helped
       l   Risk Management Life Cycle                                                   multiple companies, from startups to
                                                                                        Fortune 500 firms. ...more
       l   Hazard Identification
       l   Hazard Domains
       l   Hazard Latency Issues
       l   Risk Rating Methods                                                         Suggest a Topic       More Webinars
       l   Initial (unmitigated) Risk Assessment
                                                                                         Your Necessity is our Priority
       l   Mitigation Strategies and Priorities
       l   Mitigation Architectures

    Lecture 2: (ISO 14971):

       l   Alarm Systems as Mitigations                                                                   
       l   Risk Control Bundles
       l   Post Mitigation Risk
       l   Residual Risk
       l   Safety Integrity Levels                                              
       l   Usability as Hazard Source and Mitigation
       l   Safety Requirements
       l   Hazard Mitigation Traceability
       l   Verification Planning
       l   Architectures, Redundancy and Diversity
       l   Failure Mode and Effect Analysis / FTA
       l   Verification Strategies
       l   System Validation / Mitigation Validation

    Course Outline: Day 2:

    Lecture 3: (IEC60601-1:2005):

       l   References to Risk Management
       l   Section 4 Risk Related Issues
       l   Compliance for Non-Software Related Issues
       l   The IEC TRF (technical report form)
       l   Special PEMS Issues
       l   PEMS and IEC62304
 Lecture 4: (IEC62304):

     l   Critical Software Issues
     l   Software Hazard Mitigation Strategies
     l   Software Item, Unit and System Definition
     l   Software Failures as Hazard Sources
     l   Software Requirements and Design Specification
     l   Software Tools and Development Environment
     l   Software Unit and Integration Testing
     l   Real-Time System Challenges
     l   Software Verification and Validation
     l   Mitigation Traceability and Effectiveness

 Click here to register for this seminar

  Who Will Benefit:

     l   Project Managers
     l   Regulatory / Compliance Managers and Specialists
     l   Quality Assurance Managers
     l   System Engineering
     l   Hardware Engineers
     l   Software Engineers

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,

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