Kalpita Mehta is a combination product and medical device expert for one of the top 10 generic prescription medication manufacturers in the United States. As an engineering, regulatory, and quality management professional and medical device professional, she plays a critical role in developing and launching complex pharmaceutical and drug-device combination drug products for multiple therapeutic uses. Billions of people worldwide have benefitted from her contributions involving in-vitro diagnostic products, such as the launch of COVID-19 testing kits during the pandemic, combating opioid overdose surgical products such as wheelchairs, and other medicinal devices that alleviate upper respiratory and gastrointestinal symptoms and other critical disease states, among many other medications and products.
Kalpita additionally applies her significant experience in ISO standards for Medical Devices, Risk Management, and Lifecycle Management to promoting public safety by ensuring end-to-end quality and product compliance with the U.S. Food and Drug Administration (USFDA). Among her numerous professional licenses and certifications, she is an ASQ Certified Manager of Quality/Organizational Excellence, an ASQ Certified Quality Engineer, an ASQ Certified Quality Improvement Associate, a Six Sigma Greenbelt, and the Global Exemplar Lead Auditor for ISO 13485:2016.