Conference Description:

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


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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:
Lunch
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:

Senior Quality Managers

Quality Professionals

Regulatory Professionals

Compliance Professionals

Project managers

Risk managers

Engineering management

Quality Assurance personnel

System and design engineers

Software Engineers

Usability Engineers

Verification / validation personnel

Production Managers

Quality Engineers

Quality Auditors

Medical Affairs Professionals



AGENDA

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

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

Lecture 3: Software 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
Potentially upcoming changes (Committee Draft 3/2017)
Lecture 4: Software Risk Management
Other Software Issues
Verification of Safety Properties
Type Testing / Sample Testing
Verification Testing
Inspections
Analyses
Qualification of Manufacturing / QMS software
Fit-for-use concept
Defining the use functionality
Evaluating risks of used functionality
Creating objective evidence for use functionality
FDA Part 11 Requirements o Document Integrity
User Authorization and Authentication
User enrolment / user rights
Audit trails and data security
Cybersecurity aspects
Access Control
Data Integrity and transfer security
Threat assessements


Day 03(8:30 AM - 4:30 PM)

Lecture 5: Software And Usability In Risk Management
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
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
Lecture 6: Risk Management Report and Documentation
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



SPEAKER

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.



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