Upcoming Webinars
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Wearable and Home-use Devices Part 2: FDA Submissions
In this webinar, Tyler Ting, Director of Regulatory at Rook Quality Systems, walks you through the FDA submission landscape specific to wearable and home-use devices, so you can move from development to clearance with confidence.
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Past Webinars
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Human Body Meets Medical Device: Are We Biocompatible?
Biological risk and the biocompatibility of medical devices and their materials are coming under increasing scrutiny from regulatory agencies, which carries an increased risk of both recalls and...
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Two Years and Counting: An Update on the PREP Act and COVID-19
In this special edition webinar series, Medmarc defense panel member, Jordan Lipp, Managing Member, Childs McCune, will lead an updated discussion about the PREP Act and COVID-19 two years later and...
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Verification & Testing Strategies For Compliance With ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1
This webinar will cover the following topics: What types of medical devices will require verification testing, and how to identify what standards your device needs to test to. Key aspects of these...
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Out of EUA— FDA’s Guidance & Recommendations
In our webinar held last July about the FDA’s Emergency Use Authorization (“EUA”), presenter Jianlin Song predicted that, as we get closer to the end of the pandemic, the FDA would release guidelines...
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