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Greenlight Guru Medical Device Blog

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Title: Greenlight Guru | The #1 QMS for Medical Devices

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In the medical device industry, compliance isn’t a pop quiz. The US Food and Drug Administration (FDA), has given you all the answers to the test in the form of a regulation: 21 CFR Part 820. That doesn’t mean it’s easy to...


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In this episode, Etienne Nichols sits down with Michelle Wu, Founder and CEO of Nyquist AI and one of the top 100 women in AI, to discuss the transformative state of ...


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The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization ef...


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One of the toughest decisions for early-stage medtech companies revolves around how to build out their Quality Management System (QMS). These teams are often operating under funding pressure and tight timelines, and th...


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When it was released in 2017, the European Medical Device Regulation (EUMDR) promised high safety standards but instead created widespread regulatory friction. Even in 2018, when the medical device company I was...


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