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Risk Management


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-to-date risk management program in place you may observe deficiencies in product safety late in your product development, also may experience submission- and/ or approval delays in you regulatory process, and be open for possible enforcement action.

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:

  • requirements management

  • verification and validation

  • configuration management

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

  • risk mitigation

  • CAPA process

  • traceability

  • 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.

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