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2-day In-person Seminar

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


May 18th & 19th, 2017

Time: 9:00 AM to 6:00 PM

Zurich, Switzerland

Venue: Hilton Zurich Airport


Director : Markus Weber
  Price: $1,895.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $5,685.00
      $9,475.00 You Save: $3,790.00 (40%)*

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

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, 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 necessary steps 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
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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

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: Zurich, Switzerland Hotel: Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

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