ISO14971- Risk Management and Quality System Integration 2017

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Courtyard Arlington Crystal City/Reagan National Airport

2899 Jefferson Davis Highway Arlington, VA 22202 USA

Washington, DC 22202

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Course "Applying ISO14971 / IEC62304 / IEC62366-1 A Practical Guide On How To Implement Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


Gaps and/or incorrect or incomplete implementation of safety functionality 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 the steps necessary to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.

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.

Who Will Benefit:

  • Senior Quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Compliance Professionals
  • Project Managers
  • Design Engineers
  • Software Engineers
  • Hardware / Embedded System Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors
  • Medical Affairs Professionals


Day 1 Schedule

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 Schedule

Lecture 1:

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

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 2:

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


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.

Location: Washington, DC Date: July 20th & 21st, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Arlington Crystal City/Reagan National Airport

Address: 2899 Jefferson Davis Highway Arlington, VA 22202 USA


Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until June 10, Early Bird Price: $1,295.00 From June 11 to July 18, Regular Price: $1,495.00

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Sponsorship Program benefits for “Applying ISO14971 / IEC62304 / IEC62366” seminar

At this seminar, world-renowned Risk Management subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about Risk Management and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to Risk Management.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in Risk Management industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

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Courtyard Arlington Crystal City/Reagan National Airport

2899 Jefferson Davis Highway Arlington, VA 22202 USA

Washington, DC 22202

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