This online course is designed for professionals involved in medical device development, manufacturing, or regulation. It focuses on the real-world application of ISO 14971:2019, helping learners understand how effective risk management ensures device safety, performance, and regulatory compliance.
Developed by industry experts, the course provides clear, practical guidance on identifying hazards, analysing and evaluating risks, implementing controls, and monitoring safety throughout the product lifecycle. It also covers key concepts such as residual risk, benefit–risk assessment, and integration with quality management systems like ISO 13485.
With a structured, user-friendly approach, the course equips learners with the knowledge and confidence to apply ISO 14971:2019 effectively in practice.
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