Amit Relia, CQE, CQA, CLSSMBB

Chief Regulatory Officer

Amit-Relia

Amit Relia, CQE, CQA, CLSSMBB

Prior to joining Cleerly, Relia served as the Vice President of Quality and Regulatory Compliance at iRhythm Technologies, where he led complex regulatory initiatives for ECG-based arrhythmia detection AI SaMD products while navigating compliance milestones, including FDA Warning Letter remediation and international expansion into the UK, EU, and Japan. He has served in key leadership roles at Intuitive, where he influenced landmark compliance outcomes and regulatory clearances for its robotic surgical portfolio, and at Apple Health, where he guided the global launch of its ECG-based SaMD product on a wearable device into 47 countries.

As a leader in the MedTech industry, Relia has guided numerous innovative products, including wearables, surgical robotics, cardio and neurovascular devices, SaMD, and AI/ML diagnostics, through global regulatory landscapes. His work has resulted in several successful de novo and 510(k) submissions; focusing on creating robust, efficient, scalable quality systems to enable nimble and safe innovation.

Relia completed his Masters of Science in Management Information Systems at the University of Houston and earned his Bachelor of Science degree in Mechanical Engineering from Amravati University, India. A certified Lean Six Sigma Master Black Belt from Villanova University, he also holds certifications from the American Society for Quality (ASQ), including Lean Six Sigma Black Belt (LSSBB), Certified Quality Engineer (CQE), and Certified Quality Auditor (CQA).