Blog | Regulatory + Quality Assurance | Michelle Lott

In February 2022, FDA proposed a new Quality Management System Regulation (QMSR) to better harmonize with ISO 13485. How...

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Clients find lots of creative ways to ruin their FDA submission strategy. Doing their own research is one, and huge...

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Don't panic! Even if you were traumatized by eighth-grade algebra and sent into full PTSD by 11th-grade AP calculus, you...

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Punchline: The FDA EUA transition plans require all devices marketed under COVID enforcement policies or an EUA to submi...

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Remember what I said about MDR no longer being legislation but interpretation? Here’s another example for you: My ...

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The FDA’s biocompatibility bouncer will get you every time, no matter how many times you try to sweet-talk your wa...

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