Blog | Page 7 of 8 | Regulatory and 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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Can you explain the difference between intended use and indications for use? The terms are NOT interchangeable, but you ...

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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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Let’s face it – no one likes being told what to do, and device manufacturers are no exception. But FDA...

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Always begin with the end in mind. I say this over and over in my presentations to underscore the importance...

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We as human beings are hesitant to accept change. And this pending MDR is all change. It’s gonna change your...

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