Nidhi Vaishnav, is a Regulatory Affairs and Quality consultant focused in the medical device space. She has 15 years of experience with regulatory and quality strategy development and execution for medical devices, drug-device combination products, biosimilars, stem cell-based products and most recently, AI-based software. She comes with experience in product development, clinical testing commercialization and product lifecycle management for several markets including US, EU, Japan and rest of the world.
Nidhi has faced Due Diligences and collaborated on long term projects with Big Pharma and most recently, worked in a medical device start-up. In previous roles, she has been responsible for establishing and successfully facing the audits for an organization’s first ISO 13485 certified QMS and first product CE certification; submissions for multiple successful meetings with US FDA and EMA, clinical study applications, clinical study operations- compliance and strategy, marketing authorizations and 510(k)s. She is passionate about bringing new technologies to the market and understands the trials and tribulations of start-ups.
Nidhi presently works with Ironstone Product Development, Toronto as a medical consultant. She holds a Masters in Life Sciences from the University of Mumbai, India.