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. 

RookQS started as a small endeavor with the singular goal of helping startup companies understand the complexities of QMS and regulatory compliance. We began working with local startup companies and universities in the Atlanta area, and after some early success, began to expand our services in the Southeast region. 

Incubators in Houston and Memphis allowed Rook to grow to a larger market, and we were soon expanding to companies around the country and around the globe. We began to grow the Rook engineering team as well, with several key hires that enabled Rook to expand our quality and regulatory consulting services.  

One of our first employees was Andrew Wu, who brought his vast knowledge of SaMD and software development practices. As a startup founder, Andrew knew first-hand how important it was for small companies to keep their QMS efficient. He proved to be a perfect fit for Rook, and now leads our Taiwan Branch Office (established in 2020). Andrew and I were convinced that the future of medical devices was going to be heavily influenced by SaMD and SiMD, so we invested heavily in employees and training focused on software development and documentation.  

Along the way, we also made key partnerships that have allowed us to provide the optimal services for our clients. Greenlight.guru and their eQMS software has been an excellent long-term partner; their eQMS tool provides an out-of-the-box solution that enables companies to manage their QMS electronically.  RookQS works closely with greenlight.guru, with our consultants actively managing the QMS for our clients remotely and efficiently. We’ve also teamed up with design firms, testing facilities, authorized representatives, advisors, and notified bodies. These strategic partnerships have helped many of our medical device partners grow from an early idea to cleared medical devices with expanding markets. 

Over the past two years, we have had the amazing and gratifying opportunity to work closely with medical device companies focused on addressing the COVID-19 pandemic. RookQS has supported masks, respirators, ventilators, digital therapeutics, and over 50 COVID diagnostic devices. We’ve supported over 20 emergency use authorizations for these projects and are excited to see how the enormous efforts of the medical device community will impact devices and diagnostics going forward.  

As we look toward the future, I am incredibly excited about the opportunity to continue to lead RookQS forward, maintaining the highest level of quality and regulatory support for all medical devices. Every single day, we have the honor of helping emerging and established medical device companies bring the latest medical technology to the market, which makes this a uniquely fulfilling endeavor. From digital therapeutics, remote monitoring devices, at-home diagnostics, and countless other types of devices, we provide a critical service to assist these entrepreneurs in improving the lives of patients around the world.  We have proven time and time again that the RookQS model works for all sizes and shapes of companies to streamline the quality process, and to ensure that patients get the highest quality devices in the fastest possible time.  

As we launch our new website full of informative content, actionable information, efficient templates, and engaging training, we are excited not only for the next 10 years, but the next 100. The RookQS team now has 25 dedicated quality engineers, internal auditors, software experts, and regulatory professionals with experience in every facet of the medical device field.  Without their dedicated hard work and consistent focus on improving quality, we would not be here today supporting over 150 medical device companies. From two person startups to the biggest medical device companies in the world, RookQS provides dedicated hands-on support on a daily basis. If you need support in any aspect of your QMS, or just have general questions about starting a medical device company, we’re here to help.  

To some, quality systems may not be the most exciting part of a medical device, but it’s what we love to do, and that focus and passion is what has driven us to excel for the past decade. If you are a RookQS client past or present, please feel free to share this with your team and colleagues, and if you are not yet a client, we hope you “Look to Rook” for any medical device QMS needs.  

Thank you, 

Kyle Rose
Founder/President, RookQS