Two Day Risk Management System in Medical Devices Industry Seminar (Singapore, Singapore - November 15-16, 2018)

News provided by

Nov 01, 2018, 13:15 ET

DUBLIN, Nov 1, 2018 /PRNewswire/ --

The "Risk Management System in Medical Devices Industry" conference has been added to ResearchAndMarkets.com's offering.

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

Who Should Attend:

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

Agenda:

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
Q&A

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
Inspections
Analyses

Assurance Case Vs. Risk Management Report
General Safety And Hazard Avoidance
Device / Application Specific Issues
Tips And Tricks
Q&A

For more information about this conference visit https://www.researchandmarkets.com/research/ng4gpq/two_day_risk?w=5

Did you know that we also offer Custom Research? Visit our Custom Research page to learn more and schedule a meeting with our Custom Research Manager.

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets