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      Applying ISO14971 / IEC62304 / IEC62366-1 in Zurich

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      November 4, 2019

      Monday   8:30 AM - 4:30 PM

      Zurich, Zürich

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      Applying ISO14971 / IEC62304 / IEC62366-1

      Applying ISO14971 / IEC62304 / IEC62366-1 - A Practical Guide On How To Implement Risk Management


      Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.

      Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations.

      By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.

      Learning Objectives:

      Upon completing this course participants should:

      Understand the risk management process, the activities, and deliverables as well as the organization framework necessary

      Be able to Interpret and discuss the requirements of ISO 14971

      Develop a risk analysis framework document

      Be able to conduct risk analysis team meetings

      Recognize how and where to use the various techniques during the design life cycle.

      Understand how to apply ISO 14971 into development process

      Know how to document your Risk Management

      Explain how your Risk Management system fits into quality system and business practices.

      Perform risk assessments effectively

      Seminar Fee Includes:
      AM-PM Tea/Coffee
      Seminar Material
      Attendance Certificate
      $100 Gift Cert for next seminar

      Who Will Benefit:

      This course is relevant to managers, supervisors, QA / RA, and design/system engineers. Even experienced personnel will benefit from the "across industry" perspective and the illustration of standard practices that only a presenter with extensive experience in more than 100 projects can provide. Specific positions that would benefit are:

      Senior Quality Managers

      Quality Professionals

      Regulatory Professionals

      Compliance Professionals

      Project managers

      Risk managers

      Engineering management

      Quality Assurance personnel

      System and design engineers

      Software Engineers

      Usability Engineers

      Verification / validation personnel

      Production Managers

      Quality Engineers

      Quality Auditors

      Medical Affairs Professionals


      Day 01 (8:30 AM - 4:30 PM)

      Lecture 1: Introduction To Risk Management And Quality System Integration
      Why Perform Risk Management?
      Historical Perspective
      International Regulatory / Statutory Requirements
      Risk Management Lifecycle And Stakeholders
      Over-Reaching Concept
      Integration Into ISO13485
      Lifecycle Steps
      Risk Management Benefits
      Liability Issues
      Streamlining Product Development
      Improving Product Safety And Quality
      How To Implement Risk Management Into ISO13485
      SOP Framework
      Planning And Execution
      Monitoring And Control
      Lecture 2: Risk Management To ISO 14971:2012
      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
      Alarm Systems As Mitigations
      Risk Control Bundles
      Post Mitigation Risk
      Residual Risk
      Risk-Benefit Analysis
      Safety Integrity Levels
      European Special Requirements (Z-Annexes)
      Safety Requirements
      Hazard Mitigation Traceability
      Verification Planning
      Architectures, Redundancy, And Diversity
      Failure Rates / Modes / Types
      Failure Mode And Effect Analysis
      Tips And Tricks

      Day 02 (8:30 AM - 4:30 PM)

      Lecture 3: Software Risk Management
      Software Risk Management (IEC62304 / FDA Software Reviewers' Guidance)
      Critical Software Issues
      Software Hazard Mitigation Strategies
      Software Item, Unit, And System Definition
      Software Failures As Hazard Sources
      Software Requirements And Design
      Software Specification
      Tools And Development Environment
      Software Unit And Integration Verification / Testing
      Real-Time System Challenges
      Software Verification And Validation
      Mitigation Traceability And Effectiveness
      Software Maintenance And Configuration Control
      Software Risk Management Process - Integration Into ISO14971
      Legacy Software Issues
      FDA Documentation Requirements
      Potentially upcoming changes (Committee Draft 3/2017)
      Lecture 4: Software Risk Management
      Other Software Issues
      Verification of Safety Properties
      Type Testing / Sample Testing
      Verification Testing
      Qualification of Manufacturing / QMS software
      Fit-for-use concept
      Defining the use functionality
      Evaluating risks of used functionality
      Creating objective evidence for use functionality
      FDA Part 11 Requirements o Document Integrity
      User Authorization and Authentication
      User enrolment / user rights
      Audit trails and data security
      Cybersecurity aspects
      Access Control
      Data Integrity and transfer security
      Threat assessements

      Day 03 (8:30 AM - 4:30 PM)

      Lecture 5: Software And Usability In Risk Management
      Usability And Risk Management (IEC62366-1/-2 / FDA Human Factors Guidance)
      Use Errors As Hazard Source
      User Intervention As Hazard Mitigation
      Usability Engineering Lifecycle
      Usability Evaluation Methods
      Usability Specification
      User Interface Specification
      Formative Testing / Summative Evaluation
      Usability Verification / Validation
      The New Issues In IEC62366-1:2015
      Risk Management Report And Safety Case
      Safety / Assurance Case
      Safety Classification
      Basic Safety / Environment
      Documentation Of Basic Safety
      Electrical Safety
      Mechanical Safety
      EMC / RFI Safety
      Safety Margins
      Lecture 6: Risk Management Report and Documentation
      Documentation Of Essential Performance
      What Is Essential Performance?
      Device Architectures And Mitigation Allocation
      Device Specific Mitigations
      Software Mitigations
      External Safety
      User Intervention And Alarms
      Organizational Measures
      Levels Of Protection Concept
      Verification Of Safety Properties
      Type Testing / Sample Testing
      Verification Testing
      Assurance Case Vs. Risk Management Report
      General Safety And Hazard Avoidance
      Device / Application Specific Issues


      Markus Weber

      Markus Weber
      Principal Consultant, System Safety, Inc.

      Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. Mr. Weber 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, he 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. He has helped multiple companies, from startups to Fortune 500 firms.

      Cost: $2,289

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