Iso 24971 free download

This is a key purpose behind TIR Annex A of TIR covers the identification of hazards and characteristics related to safety. A key question within Annex A is, what is intended use? Intended use is an important thing to understand and to define with respect to your medical device. A good way to think about it is in terms of what your product claims to do. It is also a determining factor in how your product will be classified by regulatory agencies. When and how might people use your device?

What sort of abnormal uses can you envisage? Do things like off-label factor in? It can be potentially interpreted as accidental misuse, but you could also infer that someone sees another application for your product outside of what you intended. When would you be identifying these situations? Risk in general should be an innate part of your product development process. You probably think about that problem before you think of a solution and it informs what you should be doing from a risk management perspective.

At what point does reasonably foreseeable misuse come in? You should include the environment, the user, and anything that might lead to reasonably foreseeable misuse. There are pros and cons to capturing that information, and pros and cons to not doing it. Publication date : CHF Buy. Life cycle Previously Withdrawn. Final text received or FDIS registered for formal approval. Proof sent to secretariat or FDIS ballot initiated: 8 weeks. Close of voting. Proof returned by secretariat.

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