Upcoming Webinars
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FDA QSR to QMSR: Regulatory, Legal, and Risk Implications for Industry
In this webinar, Denise Holliday, Expert Witness at Capwell Consulting Group, helps you understand how the transition to QMSR may affect regulatory compliance, product liability exposure, and organizational risk.
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Past Webinars
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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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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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