Tag: predictable

Normal use or predictable abuse?

Medical devices and IVD producers must have the concepts “Normal use”, “Predictable abuse”, “Errors in expected use” AND “False application” differentiate. This is the prerequisite to understand and meet the requirements of ISO 14971 and IEC 62366. The measures that manufacturers must take also depend on the type of use. 1. Definitions and examples 1.1…