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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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Testimonials
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

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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What is A Pre-Submission (Pre-Sub)?

A Pre-Submission (Pre-Sub) is a type of Q-Submission used by medical device developers to seek feedback from the FDA on applications such as IDE, PMA, HDE, De Novo, 510(k), and CLIA Waiver. Developers can request…

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Keeping Up with the Machine: Predetermined Change Control Plans for Medical Devices

Machine learning (ML) revolutionizes the medical field by enabling faster disease detection, more accurate diagnoses, and personalized treatments. These advancements rely heavily on the vast amounts of medical data generated daily. With significant increases in…

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Navigating the Intricacies of Medical Device Software Regulations

In an ever-evolving healthcare landscape, medical device software (SMD) remains at the forefront of technological advancements and regulatory scrutiny. During a recent webinar hosted by RookQS, Alan Chen provided an in-depth analysis of current trends…

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