Training: Product Risk Management for Medical Devices (ISO 19471)
Your risk management process is an essential requirement for any Medical Device/ IVD product development and commercialization.
Can you demonstrate an efficient (up to date) risk management program when facing the approval authorities?
Does your risk management process cover all lifecycle phases including product design & development, vendor processes, all manufacturing processes and changes during commercialization?
Without a comprehensive up-
Course objectives for 2 days of training
Learn how to establish a process associated with the identification, analysis, evaluation, and control of product risks:
during design & development,
before und during manufacturing,
interfacing with your component development (e.g. software, disposables) and your vendors,
facing changes (event driven), also after product launch.
Discuss risk analysis methods and best practices:
to do risk analysis (identify, estimate and evaluate, mitigate)
to compile risk management plans & risk management reporting,
to set up overall traceability
and to structure your risk management file (RMF).
Understand the purpose, benefits, and objectives of your activities.
Learn to link risk management with your processes for:
verification and validation
Optional extension: Apply the content learned on your products/ into your environment and also create respective document templates.
lifecycle model for risk management
current ISO 14971 (2012)
regulatory requirements: ISO 13485, CFR Part 820
risk management plan & report
risk management file
acceptability of risk
qualitative and quantitative characteristics of risk
design changes during commercialization
Who Should Attend
All team members e.g. participating in an interdisciplinary medical device product development e.g. project management, system engineers; software, labeling, assay development, reagent/ instrument/ disposable manufacturing, service, quality assurance and regulatory affairs.