Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices
The Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices offered by OXQUAL develops practical knowledge of applying medical-device risk-management principles throughout product development and lifecycle activities. The programme focuses on ISO 14971:20...
About this qualification
The Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices offered by OXQUAL develops practical knowledge of applying medical-device risk-management principles throughout product development and lifecycle activities. The programme focuses on ISO 14971:2019, hazard identification, risk analysis, risk control, benefit-risk evaluation and risk-management documentation.
Career-focused
Develop relevant skills and knowledge that can support your next professional step.
What you'll cover
Key topics covered in this OXQUAL programme include:
- 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
Who it's designed for
This OXQUAL programme is suitable for:
- Medical-Device Professionals
- Quality and Compliance Personnel
- Healthcare-Technology Professionals
- Medical-Device Risk Personnel
- Product and Quality Supervisors
What you'll gain
Successful completion of this OXQUAL programme can help learners 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.
How this qualification is assessed
The assessment pattern for this OXQUAL programme is outlined below.
- 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).
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