A boutique consulting company focusing on providing clients comprehensive regulatory affairs and quality engineering services for medical device startups.
Why MDQR Solutions
With advances in machine learning and mobile technologies, companies are coming up with innovative products that promise patients a better life. It can take months and sometimes years to bring a new medical device to market. Many start-ups often lack the staff or experience to navigate the complex journey to market. As medical devices are heavily regulated, trying to do this process yourself can lead to costly errors and many companies fail to navigate the FDA review process—often collecting the wrong data and then suffering a lengthy and protracted regulatory review.
At MDQR Solutions, we focus on building a robust scientific regulatory strategy that guides companies through product submission, with a deep-dive into the supporting engineering and clinical data, followed by a structured FDA submission. With the goal of reducing the regulatory review timeline and in developing a high quality product, we collaborate with you on the entire regulatory review process and on quality engineering, from requirements to risk assessment to verification and validation strategies, and everything in between.
Prabhu's Bio
Prabhu is Founder and Principal Consultant at MDQR Solutions. He is a quality and regulatory professional with over 20 years of experience in medical devices and has held senior leadership positions in both startups and large organizations. He is also an instructor for regulatory affairs at University of California Santa Cruz. Previously, he was the VP of Regulatory and Quality at AliveCor, a startup utilizing artificial intelligence to help patients manage their arrhythmia, where he drove several 510(k) clearances, presubmissions, and a breakthrough device designation. Prior to AliveCor, Prabhu was an executive at Jan Medical, a startup focused on noninvasively detecting brain abnormalities, and at Stryker, where he held several senior leadership roles in regulatory affairs and quality assurance. Prabhu started his career developing ML algorithms for speech recognition at Bell Labs. Prabhu has 5 issued patents. He has a Master of Science in Electrical Engineering from Rutgers University and a joint MBA from University of California Berkeley/Columbia University.
University of California, Santa Cruz Courses
Mobile Health, SaMD, and AI/ML Devices. Follow link below for next class dates.
