Why “Rook”? Because getting a medical device to market is an amazingly complex challenge; not unlike a game of tournament chess. There are as many moving parts as there are pieces on a chess board. You need the perfect strategy and tactics, and that begins with your very ﬁrst move. That’s why at Rook, our mantra is “Make every move count.” We’ll be the grandmaster by your side to ensure that you never make a wrong move that could set your approval back months (or years).
We may not be experts in the Closed Sicilian or the Queens Gambit, but we ARE experts in quality and regulatory strategy for both emerging and established medical device companies. If you need to comply with regulations in domestic and international markets and time is of the essence, don’t make a move without us.
Since 2012, Rook has been dedicated to helping medical device companies develop and maintain effective and efficient quality systems, and to providing them with the right resources and expert insight. Our mission is to enable our clients to implement compliant Quality Management Systems (QMS) to ensure that they can efficiently produce effective and reliable medical devices. We build these QMSs so that our clients can get their devices to market faster than standard methods, and once on the market, manage these systems to continue producing quality devices.
Rook specializes in Quality and Regulatory strategies for early-stage medical device clientele, providing expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. Rook works with a wide range of devices, including class I-III devices, SaMD, and IVD, collaborating with your team on a holistic approach to getting your device to market as efficiently as possible.
But don’t just take our word for it—read what our partners have to say.
At Rook, we believe that quality medical devices are healthcare’s secret weapon; state-of-the-art innovations that change healthcare by expanding access to care and improving patient outcomes. We enable these secret weapons to be deployed in the most simple, eﬃcient, and timely manner possible, and that gives us our sense of purpose. Simply put: You’ve got the inspiration, we’ve got the expertise. Let’s collaborate to get your device on the market and make healthcare a little (or a lot) better.
What could be more powerful than that?
Running a business can be stressful, and audits can make it even tenser, so staying upbeat and working collaboratively towards a common goal is how we approach each and every project. Getting a medical device to market requires teamwork: Rook believes that through open communication, a positive attitude, and a team-ﬁrst approach, any obstacle can be overcome.
In the Medical Device ﬁeld, the patient comes ﬁrst. We strive to assist our clients to deliver quality devices to the market in an eﬃcient way. Ensuring quality through compliance so that innovative and safe devices get to patients and users is our highest priority.
In an industry that’s constantly changing, it’s important that we stay on our toes. We strive to stay up to date on current practices, the latest standards, and regulatory trends. We utilize the latest tools and quality improvements to continually make our processes more eﬃcient, and improve our service to our clients.
We believe that leveraging relevant technology is essential to achieving optimal results for our clients and ultimately improved outcomes for patients.