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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.

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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.

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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

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.

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
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Steps the FDA Continues to Take to Strengthen the Premarket Notification [510(k)] Program

Last week, the U.S. Food and Drug Administration (FDA) released three new draft guidances to strengthen the 510(k) program and to advance the safety and effectiveness of medical devices. A 510(k) is a premarket submission…

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What To Do (And What Not To Do) When You Receive a FDA Audit Notice

Receiving an audit notice from the FDA can be a daunting experience, but it also presents a great opportunity for your medical device company to demonstrate its commitment to patient safety and regulatory compliance. By…

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Risk Management in the Medical Device Industry – Part 2

ISO 14971 and ISO 24971: Enhancing the Safety of Medical Devices through Effective Risk Management The development and manufacturing of medical devices are critical processes that require strict adherence to safety standards to protect patients…

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