ISO 14971:2019
PQMS Academy Course
ISO 14971:2019
Medical Device Risk Management Training
Build practical understanding of ISO 14971:2019 risk management principles for medical devices, including risk analysis, risk evaluation, risk control, benefit-risk decisions, and lifecycle risk management.
Medical Device Risk Management
Designed for learners responsible for identifying, evaluating, controlling, documenting, and monitoring medical device risks throughout the product lifecycle.
Who This Training Is For
- Medical device quality assurance professionals
- Regulatory affairs professionals
- Risk management team members
- Design, development, and engineering personnel
- Manufacturing, post-market, and complaint-handling personnel
- Managers responsible for product safety and regulatory compliance
What Learners Will Cover
Risk Management Process
Risk management planning, responsibilities, risk acceptability criteria, risk files, and lifecycle expectations.
Risk Analysis
Hazard identification, hazardous situations, foreseeable misuse, sequence of events, harm, severity, and probability.
Risk Evaluation & Control
Evaluating risk acceptability, selecting risk control measures, implementing controls, and verifying effectiveness.
Benefit-Risk & Monitoring
Residual risk evaluation, benefit-risk analysis, production and post-production information, and continuous risk review.
Course Outcomes
- Understand the structure and intent of ISO 14971:2019
- Apply risk management concepts to medical device scenarios
- Identify hazards, hazardous situations, harms, and risk controls
- Understand residual risk, benefit-risk analysis, and risk acceptability
- Support compliant risk management documentation and lifecycle monitoring
Interested in ISO 14971:2019 Training?
Contact PQMS Academy for course availability, scheduling, learner registration, and custom group training options.
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