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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How to Effectively Evaluate Change and Incorporate Findings into Biocompatibility Testing and Justifications
Change Management, especially related to a medical device’s design, is one of the most commonly-cited issues in FDA 483s and Warning Letters. Unfortunately, change is constant in the medical device...
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FDA Outlook for 2022
The US Food and Drug Administration (FDA) continues to juggle enormous Covid-related responsibilities, while simultaneously attempting to make progress on a huge number of important regulatory...
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Claims 2021: Another Year Unlike Any Other
In this year’s annual year-end wrap-up, a panel that includes members of Medmarc’s Claims Department, Megan Grossman of Lewis Brisbois Bisgaard & Smith, and Karen Shimonsky of Gordon Rees Scully...
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Are there special considerations for designing medical products for the layperson?
The answer is both no and yes. It is widely believed that good design transcends the need for specialized knowledge – the product itself should demonstrate what it is capable of by utilizing its...
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