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 Human Factors is a key component of your product risk management process and why regulatory agencies are paying attention
Attendees to this webinar will learn more about the following: What is Human Factors/Usability Engineering (HF/UE) for medical products? What are the regulatory bodies asking for around HF/UE? How...
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To Repair or Not to Repair: The Shakespeare Question of 2021
This webinar will discuss legislative action across the nation surrounding the topic of the “right to repair.” What started as a competition-driven movement for electronic devices such as phones and...
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Emergency Use Authorization (EUA) - Be Aware, Be Prepared
EUA is an expedited and temporary pathway for the FDA to approve a medical product in times of emergency. Since the COVD-19 pandemic, the FDA has issued nearly 400 EUAs approving a wide spectrum of...
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Medical Device Design and Infection Prevention: What Do Manufacturers Need to Know?
A growing concern for healthcare providers is the expanding universe of drug-resistant microbes and the hospital-acquired infections that can result in complications, mortality, and morbidity....
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