2 Day Online Course Covering Risk Management in the Medical Devices Market
Dublin, March 03, 2021 (GLOBE NEWSWIRE) -- The "Risk Management 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 harm 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.
Learning Objectives:
Upon completing this course, participants should:
Understand the risk management process, the activities, and deliverables as well as the organizational framework necessary
Be able to Interpret and discuss the requirements of ISO 14971:2019
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 14971:2019 into the development process
Know how to document your Risk Management
Explain how your Risk Management system fits into quality systems 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 to 3:00 PM PST)
8.30 AM: Session Start
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
Break: Noon - 12:30 PM
Risk Management To ISO 14971:2019
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
Failure Rates/Modes/Types
Redundancy, And Diversity
Failure Mode And Effect Analysis
Tips And Tricks
Q&A
Day 02 (8:30 AM to 3:00 PM PST)
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 Life Cycle/Agile
Software as a Medical Device
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 ISO14971:2019
Legacy Software Issues
FDA Documentation Requirements
Tips And Tricks
Q&A
Break: Noon - 12:30 PM
Risk Management Report and Documentation
Documentation Of Basic Safety
Electrical Safety
Mechanical Safety
EMC/RFI Safety
Safety Margins
Documentation Of Essential Performance
What Is Essential Performance?
External Safety
User Intervention And Alarms
Organizational Measures
Verification Of Safety Properties
Type Testing/Sample Testing
Verification Testing
Inspections
Analyses
Examples and Outlines of Risk Management Documents
Tips And Tricks
Q&A
Speakers:
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.
For more information about this conference visit https://www.researchandmarkets.com/r/ldblp1
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