Bhavesh Sheth Email & Phone Number

Cleveland, Oh

Consulting for medical device design, Risk Management, testing, Global Market Research & Access, Regulatory submissions, and CertificationSubject-matter expert on medical device regulatory submissionsManaging projects, acquiring resources, assigning tasks, coordinating efforts of cross-functional teams, and providing training

Twinsburg, Oh

FDA Accredited Sr. Reviewer for 510(k) submissions of medical devicesDriven successful 510(k) submissions for a broad spectrum of medical devices under the U.S. FDA Third Party Review ProgramReviewed and managed 70+ 510(k) submissions for Class I and Class II medical devices regulated under Cardiovascular, Radiology, General Hospital, Dental, Ophthalmic, Respiratory, Orthopedic, and Physical Medicine Review Panels

Philadelphia, Pa

Designed a Fiber Optic sensor system based Probe for use during Spinal Fusion Surgery. Conducted successful experiments with bovine and porcine bone samples to validate effectiveness in differentiating between cancellous and cortical bones. Conceptualized & successfully executed experiments on human cadaver to verify and validate the performance in detecting the entrance to the vertebral pedicle. Performed statistical data analysis, prepared test reports, and presented results to the collaborating Researchers and Physicians

Skillman, Nj

Validated RF (Radio-Frequency) Wireless Clinical Monitoring System. Conducted in-house clinical tests for system evaluation and prepared test reports. Conducted literature review on potential hazards of RF energy on human tissues. Performed market research on competitive technologies and applications in Skincare. Presented design concepts and research ideas to cross-functional teams

Chennai, Tamilnadu, India

Design, Product Development, Instrumentation, Signal Processing and Analysis for Electromyograph (EMG) device and biofeedback applications

Ahmedabad, Gujarat, India

Testing, troubleshooting and maintenance of medical devices

Master Of Science (M.S.), Biomedical Engineering

Medical Science, Product Design, Research, Product Development, Testing

Bachelor Of Engineering, Biomedical & Instrumentation Engineering, 4.0 / 4.0

Medical Instrumentation, Implants, Anatomy & Physiology, Biomaterials, Medical Imaging, Signal Processing