Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices
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HiQual UK delivers the Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices, designed for learners progressing into supervisory and compliance roles in medical device manufacturing and healthcare technology. The qualification develops competence in applying ISO 14971:2019 standards, risk analysis, hazard identification, and compliance auditing. Learners gain the expertise required to oversee risk management processes, support regulatory submissions, and produce audit‑ready documentation aligned with international medical device standards (ISO 14971:2019, ISO 13485, FDA, EU MDR).
Qualification Details
| Qualification Title | Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices |
|---|---|
| Total Credits | 12 |
| Guided Learning Hours | 24 |
| Qualification Time | 48 |
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Introduction to ISO 14971:2019: Scope, objectives, and international regulatory context.
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Principles of Risk Management: Core concepts, definitions, and framework application.
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Hazard Identification in Medical Devices: Methods for detecting potential risks and failures.
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Risk Analysis Techniques: Qualitative and quantitative approaches to risk evaluation.
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Risk Evaluation and Acceptability Criteria: Determining thresholds and compliance standards.
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Risk Control Measures: Strategies for mitigation, elimination, and residual risk management.
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Benefit‑Risk Analysis: Balancing patient safety with device performance.
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Documentation and Risk Management Files: Maintaining audit‑ready records and compliance evidence.
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Regulatory and Legal Frameworks: EU MDR, FDA, ISO 13485, and global compliance requirements.
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Practical Assessment and Portfolio Development: Case studies, simulations, and audit‑ready documentation.
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Develops advanced skills in ISO 14971:2019 risk management application
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Strengthens competence in hazard identification and risk control measures
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Enhances compliance with international medical device standards and regulations
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Provides audit‑ready documentation and advanced practical assessments
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Supports progression into Level 4 and Level 5 medical device compliance qualifications
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Medical device professionals progressing into supervisory compliance roles
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Supervisors and team leaders in medical device manufacturing and healthcare technology
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Individuals seeking advanced skills in ISO 14971:2019 risk management application
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Learners preparing for higher‑level medical device compliance qualifications
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Assessment Type: Practical assessments, written exam and portfolio review
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Format: MCQs, risk management simulations, documentation tasks, oral discussion
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Total Questions: 50 theory plus multiple practical tasks
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Passing Score: 70 percent
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Duration: 10–14 weeks (160–200 hours)
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Certification: Level 3 Award in ISO 14971:2019 – Risk Management Application on Medical Devices
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