Move Count
Getting a medical device to market is an amazingly complex challenge; not unlike a game of tournament chess. You need the optimal strategy and tactics to manage all the moving parts. With Rook, you’re partnering with a grandmaster to ensure that you never make a wrong move that could set your approval back months (or years).
We leverage a decade of experience, expertise, and established best practices to build customized QMS so you can get your devices to market significantly faster than standard industry methods.
March 2022 is a momentous time for RookQS, as it officially marks our ten-year anniversary as a company. To celebrate, we’ve launched a new website with a plethora of great content, as well as information on our growing team, and easier access to RookQS resources. We thought we’d highlight some of the growth over the past ten years with this blog.
Andrew Wu – AI Product in Healthcare
https://www.youtube.com/watch?v=KiTJL0JRoR4 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…
Understanding the FDA’s Final CDS Guidance
The Final Clinical Decision Support (CDS) Guidance, describes the FDA’s regulatory approach to Clinical Decision Support (CDS) software functions. Suffice it to say that much of the previously designated non-device CDS software might no longer…
UKCA Mark Delay – How to Capitalize on the Extension
On October 21, 2022, the Medicines & Healthcare Products Regulatory Agency (MHRA) announced that they are adding a twelve-month extension to the current standstill period on future Regulation for Medical Devices, aiming to bring the…