Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices
The PIMS Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices develops practical knowledge of applying medical-device risk-management principles throughout product development and li...
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Program Overview
The PIMS Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices develops practical knowledge of applying medical-device risk-management principles throughout product development and lifecycle activities.
The programme focuses on hazard identification, hazardous situations, device failure modes, risk analysis, risk acceptability, risk controls, residual risk, benefit-risk evaluation and structured medical-device risk documentation.
What You'll Learn
- ISO 14971:2019 Fundamentals
- Medical-Device Risk Management
- Risk-Management Terminology
- Hazard Identification
- Hazardous Situations
- Device Failure Modes
- Risk Analysis
- Qualitative Risk Evaluation
- Quantitative Risk Awareness
- Risk Acceptability
- Risk-Control Measures
- Risk Reduction
- Residual Risk
- Benefit-Risk Analysis
- Risk-Management Plans
- Risk-Management Files
- Post-Production Information Awareness
- ISO 13485 Awareness
- EU MDR Awareness
- FDA Regulatory Awareness
- Medical-Device Risk Documentation
Empowering professionals with knowledge, practical understanding and stronger workplace skills.
PIMSWho Should Attend?
This PIMS medical-device risk-management course is suitable for Medical-Device Professionals, Quality and Compliance Personnel, Healthcare-Technology Professionals, Medical-Device Risk Personnel and Product and Quality Supervisors.
Key Benefits
After completing the programme, learners should be better prepared to:
- Develop ISO 14971:2019 application knowledge
- Strengthen hazard-identification competence
- Improve medical-device risk analysis
- Develop risk-control planning skills
- Improve benefit-risk evaluation
- Strengthen risk-management documentation
Assessment & Evaluation
- Assessment Type: Practical assessments, written examination and portfolio review.
- Format: Multiple-choice questions, risk-management simulations, documentation tasks and oral discussion.
- Total Questions: 50 theory questions plus multiple practical tasks.
- Passing Score: 70%.
- Duration: 10–14 weeks (160–200 hours).
Start Your Professional Learning Journey.
Contact PIMS for information about Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices, training schedules and enrollment.
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