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Applying ISO14971 and IEC62304 2017 at Singapore

Monday, May 22, 2017 at 9:00AM - Tuesday, May 23, 2017 at 6:00PM

Mandarin Orchard Singapore

  • May 2017

    22 Mon


  • May 2017

    23 Tue


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Applying ISO14971 and IEC62304 2017 at Singapore

Monday, May 22, 2017 at 9:00AM - Tuesday, May 23, 2017 at 6:00PM


No tickets available


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.

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

  • Why
    risk management?
    • Historical perspective
    • International regulatory / statutory
  • 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

    • 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
      • Safety Integrity Levels
    • European special requirements (Z-Annexes)
    • Safety Requirements
    • Hazard Mitigation Traceability
    • Verification Planning
    • 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'

  • 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'

  • 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 performance
  • 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
    • User intervention and alarms
    • Organizational measures
    • Levels of protection concept
  • Verification
    of safety properties
    • Type testing
    • Sample testing
    • 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. 

 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: Singapore Date: May
22nd & 23rd, 2017 and Time: 9:00 AM to 6:00 PM


Venue: Mandarin
Orchard Singapore

Address: 333 Orchard Road, Singapore




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 20, 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



Registration Link - ezevent_may_2017_SEO

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