Begin Your Risk Analysis with Intended Use and Foreseeable Misuse
Exeed Regulatory Compliance
OCTOBER 12, 2020
The final scope and definition of the intended use is developed based on the target medical purpose, patient and user profiles, location in the body, use environment and the operating principle. Reasonably Foreseeable Misuse: The keyword here is “reasonable”. Let us take the example of a disposable face mask.
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