Blog | Page 4 of 16 | Regulatory + Quality Assurance | Michelle Lott

How do you go about choosing the right predicate device? Say you’ve developed a new tree-borne fruit and you need...

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You KNOW your proposed deregulation of medical devices is a bad decision when even the device manufacturers ask you to...

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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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FDA made it easier to commercialize 91 risky medical devices. You can help reverse the ruling: 2 easy steps, 5 minutes. ...

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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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