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Risk Management System in Medical Devices Industry (com) A

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Sydney, NSW 2000


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Risk Management System in Medical Devices Industry


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 harms 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.

By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.

Learning Objectives:

Upon completing this course participants should:

  • Understand the risk management process, the activities, and deliverables as well as the organization framework necessary

  • Be able to Interpret and discuss the requirements of ISO 14971

  • 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 into development process

  • Know how to document your Risk Management

  • Explain how your Risk Management system fits into quality system and business practices.

  • Perform risk assessments effectively

Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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


Day 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration
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

Day 02(8:30 AM - 4:30 PM)

Lecture 3: 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
Lecture 4: 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 5: 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
Assurance Case Vs. Risk Management Report
General Safety And Hazard Avoidance
Device / Application Specific Issues
Tips And Tricks


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.

Please contact the event manager Marilyn (marilyn.b.turner@nyeventslist.com ) below for:

- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships

Service fees included in this listing.
This event is brought to you by:
METRICSTREAM INC - New York Events List


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Sydney, NSW 2000


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