Blog | Page 2 of 16 | Regulatory + Quality Assurance | Michelle Lott

(This is an edited transcript of the video clip, but here’s the link to the full presentation) Do you...

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(Edited Transcript – link to the full presentation) How do you make the business case for MDR? You need...

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MDR and miniature dollhouses are much more similar than you might think. Almost frighteningly so. A few weeks ago, my...

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The recent reclassification of blood lancets by the FDA may or may not have caught you by surprise. To bring...

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We led an effort to overturn an FDA rule to down-classify 91 devices to Class 1 or 2 and make them 510(k) exempt....

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As a certified regulatory grief counselor, I am asked about FDA submission pathways all the time. These questions typica...

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