Skip to content

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

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.

Learn more
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,…

Read more
Medical Ai, hands of robot and human touching.

The FDA’s Artificial Intelligence Program’s Role in Addressing Regulatory Challenges in AI-Driven Medical Devices

Overview Artificial intelligence (AI) technologies have ushered in a new era in healthcare, fundamentally altering how medical decisions are made. These advancements extend across various domains of medical devices, from enhancing image acquisition and processing…

Read more
Concept of brainstorming

Key Strategies for Successfully Executing the Design Transfer Process

Design Transfer is the critical process of moving a medical device from prototype or early development to full-scale production. It can be involved in scenarios such as, transitioning from internal development to contract manufacturing for…

Read more
A person on a laptop.

Essential Tips for Preparing for Your ISO 13485:2016 Stage 1 Audit

An ISO 13485:2016 audit is a comprehensive evaluation process conducted to verify that a medical device manufacturer's quality management system (QMS) meets the requirements of the ISO 13485:2016 standard. This standard specifies the requirements for…

Read more
Subscribe to our Newsletter
Join our mailing list for the latest Rook events, thought leadership, and more.
Back To Top