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In February 2022, FDA proposed a new Quality Management System Regulation (QMSR) to better harmonize with ISO 13485. How...
Learn MoreIn category: ISO-13485 LinkedIn Regulatory Quality
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...
Learn MoreIn category: Regulatory Quality