RookQS helped us with our quality services from inception, assisting us to scope and instantiate a compliant quality management system.
The level of the service and support we’ve received has been outstanding, and I have no hesitation recommending them to other clients in our medical device industry.
Dianyx Innovations engaged RookQS to support our efforts in pursuing 510k approval for our flagship product- a technology-enhanced sleep appliance (t.e.s.a.)
After working with a previous FDA consultant, Rook’s experience, professionalism, and process-driven approach were refreshing to say the least.
RookQS quickly aided in preparing Dianyx for pre-submission – developing the correct documentation, and supporting our team in the compilation while interfacing with the FDA to schedule the meeting.
I would recommend RookQS to start-ups and established companies for support in their journey towards regulatory approval.
In 2022, recognizing the need for FDA compliance for ZiphyCam, we sought expert advice. The personable and knowledgeable RookQS team stood out among consultants, leading us to choose them. Their assistance in implementing and maintaining our QMS for ZiphyCam was seamless. Their willingness to share expertise in an accessible manner has made our partnership enjoyable. We’re extending our collaboration with Rook to include the ZiphyKit. I strongly endorse RookQS for any company seeking trustworthy, personable, and genuine subject matter experts.
I am immensely grateful for the exceptional support provided by the RookQS team during the implementation of our QMS at Xandar Kardian. Their steadfast dedication and proficiency in navigating the complexities of QMS in a startup environment, coupled with their seamless collaboration across different time zones, have significantly accelerated our preparations for the impending MDSAP audit. The team’s expertise in simplifying intricate processes, prompt delivery of a detailed Gantt chart, and meticulous documentation through meeting minutes and charts have set a commendable benchmark for our vendors. I confidently recommend RookQS to any organization in need of reliable and knowledgeable partners, as their invaluable contribution has greatly impacted our QMS implementation success at Xandar Kardian.
The Rook team has been spectacular. They are very responsive and detail-oriented. The most positive feedback I’ve heard is from FDA and ISO inspectors. One ISO inspector said that as a result of Rook’s work, the Stage 1 audit was one of the best she’s reviewed in 10 years. An FDA inspector was similarly complimentary, saying the Rook team was deeply knowledgeable and professional.
I couldn’t recommend Rook more. I think they’re phenomenal and have been a blessing for our company.
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.
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.
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,…
Understanding How to Properly Evaluate Suppliers per FDA Requirements 21 CFR 820.50
Purchasing Controls and Supplier Evaluations are a critical component of quality management for medical device manufacturers, ensuring that materials, components, and services provided by third parties meet the necessary standards for safety and compliance. Per…
Small Business Determination Requests Now Accepted Through CDRH Portal
The FDA recently released a significant update to its Center for Devices and Radiological Health (CDRH) Portal, allowing medical device companies to send premarket submissions and Small Business Determination (SBD) requests online. This new feature…
FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices
The FDA recently released a 45-page draft guidance detailing the use of chemical analysis in biocompatibility assessments for medical devices. This guidance provides manufacturers with critical recommendations on how to collect and report chemical characterization…