Beginner (No knowledge at all of the topic).
This two-day course is designed to provide participants with a comprehensive understanding of ISO 14971:2019, the international standard for risk management of medical devices. The course will cover the essential principles, concepts, and requirements of the standard, and provide practical guidance on how to apply them in real-world situations.
ISO 14971:2019, provides the processes for identifying, evaluating, and mitigating hazards associated with the use of medical devices. While not mandatory, it is the most commonly used, industry-recognized standard to demonstrate conformity to when addressing product safety requirements.
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