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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
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FDA eSTAR Program: Three Main Benefits

More than a year ago, we explained the main benefits of the FDA eSTAR Program for 510(k) and De Novo filings. This information remains accurate, and is more relevant than ever because starting October 1,…

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A Guide to Etiquette and Preparation for Your First FDA Audit

Mastering Your First FDA Audit: A Guide to Etiquette and Preparation Following the COVID-19 pandemic, there has been a significant increase in FDA inspections as inspectors strive to catch up with the disruptions caused by…

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Guidelines for Verifying Laboratory Testing Data Before FDA Submission

FDA's Response to Data Integrity Issues The FDA recently expressed concern regarding the rise of fraudulent and unreliable laboratory testing data in premarket submissions. The agency has identified a growing issue with the integrity of…

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QMSR Final Rule Webinar



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