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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 harm 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.

Learning Objectives:

Upon completing this course, participants should:

  • Understand the risk management process, the activities, and deliverables as well as the organizational framework necessary
  • Be able to Interpret and discuss the requirements of ISO 14971:2019
  • 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 14971:2019 into the development process
  • Know how to document your Risk Management
  • Explain how your Risk Management system fits into quality systems and business practices.
  • Perform risk assessments effectively

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:

  • 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

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM to 3:00 PM PST)
  • 8.30 AM: Session Start
  • 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
  • Break: Noon – 12:30 PM
  • Risk Management To ISO 14971:2019
    • 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
    • Failure Rates / Modes / Types
    • Redundancy, And Diversity
    • Failure Mode And Effect Analysis
    • Tips And Tricks
    • Q&A
Day 02(8:30 AM to 3:00 PM PST)
  • 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 Life Cycle / Agile
    • Software as a Medical Device
    • 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 ISO14971:2019
    • Legacy Software Issues
    • FDA Documentation Requirements
    • Tips And Tricks
    • Q&A
  • Break: Noon – 12:30 PM
  • Risk Management Report and Documentation
    • Documentation Of Basic Safety
      • Electrical Safety
      • Mechanical Safety
      • EMC / RFI Safety
      • Safety Margins
    • Documentation Of Essential Performance
    • What Is Essential Performance?
    • External Safety
    • User Intervention And Alarms
    • Organizational Measures
    • Verification Of Safety Properties
      • Type Testing / Sample Testing
      • Verification Testing
      • Inspections
      • Analyses
    • Examples and Outlines of Risk Management Documents
    • Tips And Tricks
    • Q&A
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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March 3-4, 2021, Virtual Seminar
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(Registrations after February 5, 2021 - $2299)

$9,685.00

Group-Max. 10 Attendees

March 3-4, 2021, Virtual Seminar
(Registrations till February 5, 2021 - $9685)
(Registrations after February 5, 2021 - $11395)



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