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Risk Management in Medical Devices Industry Seminar: Learn the Main Elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2 - Tampa, United States - September 26-27, 2019

DUBLIN, Aug. 28, 2019 /PRNewswire/ -- The "Risk Management in Medical Devices Industry" conference has been added to's offering.

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:

  • 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

Who Should Attend:

  • Project managers
  • Risk managers
  • Engineering management
  • Quality Assurance personnel
  • Regulatory and Compliance professionals responsible for FDA / notified body interactions
  • System and design engineers
  • Software Engineers
  • Usability Engineers
  • Verification / validation personnel
  • Production Managers


Day 1

08.30 AM - 09.00 AM: Registration

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
  • Q&A

Day 2

Lecture 3: Software And Usability In 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
  • Tips And Tricks

Lecture 4: 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

Lecture 5: 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
  • 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
  • Inspections
  • Analyses
  • Assurance Case Vs. Risk Management Report
  • General Safety And Hazard Avoidance
  • Device / Application Specific Issues
  • Tips And Tricks
  • Q&A

For more information about this conference visit

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