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,…
Breaking Down the FDA Draft Guidance on Lifecycle Management and Marketing Recommendations for AI-Enabled Devices
The FDA's draft guidance, "Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations," supports a Total Product Lifecycle (TPLC) approach to overseeing AI-driven medical devices. It outlines recommendations for marketing submissions, documentation requirements,…
Key Insights Into the FDA’s Updated GUDID Guidance
On December 17th, 2024, the Food and Drug Administration (FDA) issued an updated final guidance on submitting data to the Global Unique Device Identification Database (GUDID). This document replaces the guidance originally published in June…
4 Bold Predictions Shaping Medical Device Quality in 2025
As 2025 approaches, the medical device industry stands on the brink of transformative changes. To help you stay ahead, we asked our CEO and Founder, Kyle Rose, to share his expert insights. From the growing…