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Want To Ace
Your Next Audit?

The key to no findings is simple: finding the right partner. Rook has an experienced team of Certified Quality Auditors for a variety of regulations including FDA 21 CFR820, ISO 13485:2016, MDSAP, and CE Mark under MDR.

Look to Rook
Need Help Navigating the Quality System for the First Time?

Rook’s quality consultants will create a custom QS for your company that is both efficient and easy to maintain. Our systems are audit ready and continually updated to ensure compliance.

Expert Navigation
Struggling With the Complexities of Risk Management?

Rook will work with your company to develop a comprehensive risk management platform for products and processes, including the use of PHAs, FMEAs (process, use, design, and software).

Instant Simplification
Realizing the
Devil’s In The
Documentation?

If you didn’t document it, it didn’t happen (as far as the FDA and other regulatory bodies are concerned). Rook helps clients compile and maintain Quality Records documents that detail compliance history.

Rook to the Rescue
Make Every
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.

NEWS
Rook Quality Systems: Celebrating a Decade of Gratitude and Growth

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.

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Featured Resources

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…

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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…

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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…

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