Putting this into practice
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Request Free AssessmentThe II b risk category, under EU Medical Device Regulation (MDR) 2017/745, designates medium-to-high risk medical devices. This includes AI software used for diagnosis or therapeutic decisions where an incorrect output could cause significant patient harm. Products in this class require stringent conformity assessment by a Notified Body.
Curated by Winners Consulting Services Co., Ltd.
Winners Consulting helps organizations turn this concept into workable policies, processes and audit readiness.
Need help with compliance implementation?
Request Free Assessment