From MedTech Innovator to Compliance Visionary
Sangeetha B’s journey in biomedical innovation began with a powerful inspiration from her mentor, Professor Manivannan M of the Department of Applied Mechanics and Biomedical Engineering at IIT Madras. From the outset, Professor Manivannan instilled in her the conviction that “what we innovate towards healthcare should reach people easily, and the best healthcare-related innovation should not stop from any hurdles.” Guided by this principle, Sangeetha immersed herself in research as a Project Associate and Master’s student at IIT Madras, dedicating over five years to developing advanced medical technologies—including wearable sensors, AI-integrated health monitoring systems, and VR-based physiological simulations. Her standout innovations, such as a Smart Fetal Heart Monitor with 97% accuracy and a Haptic Wearable for the Visually Impaired, reflected her deep commitment to addressing real-world healthcare challenges through technology.
You can build the smartest device in the world, but without compliance, it never leaves the lab. Real innovation scales only when quality leads the way.” — Sangeetha B
Despite building impactful prototypes, Sangeetha realized that many innovations failed to reach end users and create meaningful clinical outcomes—not due to technological shortcomings, but because of compliance hurdles like the absence of structured quality systems, regulatory documentation, and design control frameworks. As she often emphasizes, “You can build the smartest device in the world, but without compliance, it never leaves the lab. Real innovation scales only when quality leads the way.” A pivotal moment came during a course by Prof. Ramakrishnan S at IIT Madras, where Sangeetha was introduced to regulatory and quality compliance as a strategic tool—an advantage leveraged by top MedTech OEMs to scale globally. Through discussions with experienced regulatory and quality experts, she discovered that while large companies could afford multinational service providers to handle compliance, startups had no such accessible, aligned partners.
This realization, combined with the foundational inspiration from Professor Manivannan, sparked a new mission: to democratize compliance and make it a launchpad—not a barrier—for innovation. Sangeetha founded Qualentra Global alongside experienced regulatory and quality professionals, united by a vision to support early-stage MedTech innovators. What sets Sangeetha apart is her ability to connect deep R&D understanding with regulatory strategy, speaking the language of engineers while building ISO 13485-aligned QMS, risk frameworks, and tailored regulatory pathways. Rooted in empathy and her own journey, she now simplifies compliance so others can succeed faster. Today, through Qualentra, Sangeetha empowers MedTech teams to design with compliance from Day 1, navigate audits confidently, and unlock funding with regulatory-ready submissions—proving that true innovation needs structure, and compliance can be its strongest ally.