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How do you go about choosing the right predicate device? Say you’ve developed a new tree-borne fruit and you need...
Learn MoreIn category: FDA Approval LinkedIn Regulatory Quality
Clear some space on your regulatory bookshelf! You’re going to need room for your copy of the UK’s newly-ado...
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Can you explain the difference between intended use and indications for use? 🤔 The terms are NOT interchangeable, but...
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Blame the snake-oil salesmen. It’s mostly their fault that we ended up with so much medical device regulation in t...
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Acceptance: The Fifth Stage of Regulatory Grief (video) Let’s face it – no one likes being told what to do,...
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Regulatory Depression? Blame Bad Design Controls (Video) The regulatory submission process can leave most anyone depress...
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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:
Winning in the marketplace!