Best Practices for Applying ISO14971 and IEC62304 in Zurich

Thursday, May 18, 2017 at 9:00AM - Friday, May 19, 2017 at 6:00PM

Event Details


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.

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

Who Will Benefit:

The course will
introduce the main elements of risk management with emphasis on the application
of risk management principles and requirements to the medical device
development cycle. Risk management has become the method of choice to ensure an
effective and safety oriented device development. International consensus,
reflected in globally applicable standard requirements, has led to risk
management being a mandatory component of almost any activity in the medical
device industry.

The course will
emphasize the implementation of risk management into the development and
maintenance process. It will use real-life examples and proven tips and tricks
to make the application of risk management a practical and beneficial
undertaking. This seminar will address the system level issues of risk
management as well as the increasingly important software and usability related
issues of critical systems. It will help to comply with regulatory requirements
with minimized overhead and resource burden. To make the combines effort to
design, implement and verify a safe device transparent the concept of an assurance
case will be introduced.

The course is
mainly based on international consensus requirements such as ISO14971, IEC62366
and IEC62304. It will cover European (MDD), US (FDA) and international risk
management requirements from a regulatory and practitioner's perspective.

Following personnel will benefit from
the course:

  • Senior
    quality managers
  • Quality
  • Regulatory
  • Compliance
  • Project
  • Design
  • Software
  • Process
  • Quality
  • Quality
  • Medical
  • Legal


Day 1 Schedule:

Introduction into Risk Management and Quality System Integration

  • Why
    risk management?
    • Historical
    • International
      regulatory / statutory requirements
  • Risk
    Management Lifecycle and stakeholders
    • Over-reaching
    • Integration
      into ISO13485
    • Lifecycle
  • Risk
    Management Benefits
    • Liability
    • Streamlining
      product development
    • Improving
      product safety and quality
  • How
    to Implement Risk Management into ISO13485
    • SOP
    • Planning
      and execution
    • Monitoring
      and control

Lecture 2:Risk Management to ISO 14971:2012

    • Risk
      Management Planning
    • Risk
      Management Life Cycle
    • Hazard
      • Hazard
      • Hazard
        Latency Issues
      • Risk
        Rating Methods
    • Initial
      (unmitigated) Risk Assessment
    • Mitigation
      Strategies and Priorities
    • Mitigation
      • Alarm
        Systems as Mitigations
      • Risk
        Control Bundles
    • Post
      Mitigation Risk
    • Residual
      • Safety
        Integrity Levels
    • European
      special requirements (Z-Annexes)
    • Safety
    • Hazard
      Mitigation Traceability
    • Verification
    • Architectures,
      Redundancy and Diversity
    • Failure
      Mode and Effect Analysis
    • Tips
      and Tricks
    • Q&A

Day 2 Schedule:

Usability and Risk Management

  • Use
    errors as hazard source
  • User
    intervention as hazard mitigation
  • Usability
    engineering lifecycle
  • Application
  • Usability
  • Frequently
    used functions / primary operating functions
  • Usability
    verification / validation
  • Upcoming
    changes IEC62366:2014

Lecture 2: 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

Lecture 3: Software Risk
Management (IEC62304 / FDA software reviewers' guidance):

  • 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

Lecture 4: Safety /
Assurance case

  • Safety
    • Basic
      Safety / Environment
    • Essential
  • Documentation
    of Basic Safety
    • Electrical
    • Mechanical
    • EMC
      / RFI safety
    • Safety
  • Documentation
    of essential performance
    • What
      is essential performance?
    • Device
      architectures and mitigation allocation
    • Device
      specific mitigations
    • Software
  • External
    • User
      intervention and alarms
    • Organizational
    • Levels
      of protection concept
  • Verification
    of safety properties
    • Type
    • Sample
    • 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


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 Date: May 18th
& 19th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Hilton
Zurich Airport

Address: Hohenbuhlstrasse 10, 8152
Opfikon-Glattbrugg, Switzerland


now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until April 10, Early Bird Price:
$1,695.00 from April 11 to May 16, Regular Price: $1,895.00

Register for 5 attendees  
Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)*


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Phone: 1-800-447-9407

Fax: 302-288-6884

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Organization Details

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

Zurich, Switzerland
Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50
Zurich 8152

Starts May 18, 2017 at 9:00AM
Ends May 19, 2017 at 6:00PM

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Contact Information

Organization: GlobalCompliancePanel

Event Contact: John Robinson

Phone: 1-800-447-9407