Blog | Page 4 of 8 | Regulatory and Quality Assurance | Michelle Lott

This conversation is part of Arazy Group Consultants’ Regulatory Rockstar Movement, which I was invited to partici...

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As you must know by now, the FDA made eSTAR 5.0 mandatory for 510(k) submissions in October 2023. It’s also...

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Imagine, if you will, an established medical device player and their newly-acquired subsidiary trying to flex their comb...

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Aren’t design controls and risk controls essentially the same thing? Uh, no. They are similar, but in the end, ver...

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I recently caught up with my buddy Randy Horton over at Orthogonal, and we did a deep dive into the...

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Note: QMSR became mandatory in February 2026, three years after this blog was written. Please see the closing for up...

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