As I have stated previously, MDR does not define state-of-the-art or standard-of-care.
But it does mention state-of-the-art eleven times.
So how does MDR expect state-of-the-art to be part of the new regulation if it doesn’t clearly define what that is?
Good question. But hopefully this little video will help clear up some of the confusion: https://youtu.be/T1GS9WmkA_8
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Michelle Lott and the leanTeam help clients recognize regulatory and quality issues aren't a "burden" – they are strategic advantages when used properly. The expert team will also strip away any redundant or misdirected activities so you can focus on what really matters:
