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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FDA Policies: Reflecting on the Past, Understanding the Present, and Preparing for the Future
Join Rick Quinn and Jennifer Diaz from Diaz Trade Law as they discuss FDA Policies: Reflecting on the Past, Understanding the Present, and Preparing for the Future.
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Private Labeling of Medical Devices in the U.S.
Join Sarah Lacey Robbins from RookQS as she discusses Private Labeling of Medical Devices in the U.S.
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Medical Device v2.0: Safer but Riskier?
Join Clark Hill PLC Member Matt Marshall as he discusses the requirements of GMP relating to product improvement, the potential risks of such improvements in litigation, and how such improvements may run afoul of a device’s existing FDA clearance.
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Developing and Maintaining an FDA Compliant Complaint Handling Process
Join Sarah Lacey Robbins from RookQS as she discusses developing & maintaining an FDA compliant complaint handling process.
Read More about Developing and Maintaining an FDA Compliant Complaint Handling Process