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
Making the Business Case for MDR (or Whether It’s Worth Selling in Europe)
(Edited Transcript – link to the full presentation) How do you make the business case for MDR? You need
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The Sad Tale of Denial and the Poor Pre-Market Strategy
You’ve heard me tell you often enough that the first stage of regulatory grief is denial. And over the past
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Is MDR Certification Worth 5% of Your Revenue?
I posted about the costs of MDR certification last year, and warned companies that achieving certification would be a sizable
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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:
