Webinars

AI Product in Healthcare – Andrew Wu

November 23, 2022

 Agenda: Applications of AI in Medicine & Healthcare. Risk of using AI in Healthcare from a stakeholder’s point of view. Risk of approving AI in Healthcare from a regulator’s point of view. Risk Management…

Preparing For Your First FDA or ISO Audit

August 9, 2022

Our recent blogs on preparing for your first FDA inspection and/or ISO audit generated a lot of interest, and a lot of follow-up questions from emerging med device companies all over the globe. We asked…

MDR Transition and Technical Files: What You Need to Know

June 10, 2022

Recent changes to European regulations have sparked a lot of interest and intrigue, and even more questions. So, what specifically do medical device companies need to know about these MDR and TF changes? In this…

Rook QS Webinar: First FDA Software Updates in 16 Years

November 23, 2021

On Monday, November 22nd, Rook's Kyle Rose and Andrew Wu, two of the industry's foremost experts on quality and regulatory strategy in the software space, presented a webinar addressing the first new regulations the FDA…

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