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Seminar on Risk Management in Medical Devices Industry  

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By:

Global Compliance Panel   

For:

Senior Quality Managers, Quality Professionals, Regulatory Professionals, Compliance Professionals, Project Managers, Design Engineers, Software Engineers, Process Owners, Quality Engineers Quality Auditors, Medical Affairs, Legal Professionals

Cost:   

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Seminar Summary:

This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information. (see full course description)

 

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Training Course Syllabus:


Risk Management in Medical Devices Industry 2016

Overview:

Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software.

To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the ΄Safety Case΄ or ΄Assurance Case΄ document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

Agenda:

Day 1 Schedule:

Lecture 1:
Introduction into Risk Management and Quality System Integration
• Why 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
• Tips and tricks
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
  Safety Integrity Levels
• European special requirements (Z-Annexes)
• Safety Requirements
• Hazard Mitigation Traceability
• Verification Planning
• Architectures, Redundancy and Diversity
• Failure Mode and Effect Analysis
• Tips and Tricks
• Q&A


Day 2 Schedule:

Lecture 1:
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 Specification
• Software Tools and Development Environment
• Software Unit and Integration 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
• Upcoming changes in IEC62304:2014
• Tips and Tricks
• Q&A
Lecture 2:
Safety / Assurance case
• Safety classes
  Basic Safety / Environment
  Essential performance
• Documentation of Basic Safety
  Electrical Safety
  Mechanical Safety
  EMC / RFI safety
  Safety margins
• 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
  Software verification testing
  Inspections
  Analyses
• Assurance case vs. Risk Management Report
  General safety and hazard avoidance
  Device / application specific issues
• Tips and Tricks
• Q&A


Speaker:

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. 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.

Seminar Summary:

This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information. (see full course description)

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