Rook Quality Systems is proud to welcome Tyler Ting as our new Director of Regulatory, bringing a wealth of experience in medical device regulatory affairs, quality systems, and startup consulting. With a unique blend of technical expertise and hands-on experience, Tyler is dedicated to helping MedTech innovators bring safe, effective, and compliant technologies to market.
Tyler began his professional journey with dual degrees in Biochemistry and Mechanical Engineering from CU Boulder, driven by a passion for healthcare innovation. He started as a project management intern at a medical device company and quickly realized the pivotal role of quality and regulatory teams in guiding medtech innovation.
He progressed to leading software as a medical device (SaMD) projects, gaining mentorship that shaped his regulatory approach. Tyler later contributed to global leaders like Medtronic and Stryker, working on international regulatory submissions, U.S. post-market compliance, and EU MDR transitions.
During the COVID-19 pandemic, he joined an IVD startup, submitting an Emergency Use Authorization (EUA) for an antigen test. That experience sparked his passion for startups, leading him to consulting, where he has guided medtech innovators for the past three years.
Tyler was drawn to Rook by our vision, leadership, and history of working with novel technologies.
"When I spoke with Kyle Rose, I was impressed with the leadership, vision, and history of RQS,” Tyler said. “The opportunity to work with clients developing innovative technologies and preparing for regulatory submissions excited me.”
Tyler’s first job in his family’s Chinese restaurant taught him the value of customer service, attention to detail, and delivering high-quality results, lessons that carry over to consulting today. He emphasizes that strong client relationships and producing regulatory-compliant submissions are at the core of helping medical device companies succeed.
As Director of Regulatory, Tyler’s focus is on deepening Rook’s regulatory expertise and strengthening strategies for complex submissions. His priorities include:
Expanding regulatory guidance for FDA and international submissions
Enhancing accuracy in regulatory risk assessment
Supporting clients in navigating complex FDA interactions
Advancing regulatory strategies for emerging technologies like AI/ML-enabled devices
Tyler’s expertise spans premarket design and development of Class II devices, FDA 510(k) notifications, EU MDR remediation, international regulatory submissions, and post-market compliance. He has a particular interest in the rapid growth of AI and machine learning in medical devices, supporting clients with Predetermined Change Control Plans (PCCPs) and other advanced regulatory pathways.
Tyler emphasizes that successful consulting partnerships rely on communication, accountability, and trust. By understanding each client’s technical strengths, priorities, and resource limitations, Tyler helps MedTech innovators navigate the regulatory landscape efficiently while meeting compliance standards.
“A deep integration between consultant and client ensures clear expectations and effective regulatory documentation,” he explains.
Tyler sees regulation evolving alongside innovations in AI, digital health, and combination products. While regulatory requirements can be complex, proactive engagement with agencies like the FDA ensures that safe, effective innovations reach patients quickly.
He also believes that streamlining real-world clinical data collection for lower-risk devices could accelerate regulatory approvals and innovation, creating benefits for both manufacturers and patients.
He views FDA requirements not as obstacles, but as frameworks that protect patient safety while enabling technological advancement. By building trust with regulators, Tyler helps MedTech companies navigate hurdles efficiently and focus on delivering impactful solutions.
Tyler’s passion for healthcare stems from personal experiences with preventable cardiovascular diseases in his family. He is driven to improve patient outcomes through innovative medical devices. He also resonates strongly with Rook’s values of teamwork, positivity, and collaboration, which he believes are essential for overcoming challenges in quality and regulatory spaces.
When he’s not advancing medical device innovation, Tyler enjoys spending time with his two young children, exploring Colorado’s outdoors, running, mountain biking, skiing, and walking to recharge and stay engaged with technology trends.
Rook Quality Systems is excited to have Tyler leading regulatory strategy and supporting MedTech startups and established companies alike. With his expertise, vision, and commitment to patient-centered innovation, Tyler is a driving force behind Rook’s mission: empowering medical device companies to achieve regulatory success and deliver life-changing technologies to market.