Ashwini Kumar

Ashwini Kumar is a seasoned professional in quality management and regulatory compliance within the medical device industry, currently serving as the Director of Medical Device Compliance at Consltek, Inc. Ashwini has substantial experience as a Principal Consultant at Garani Consultants and has held significant roles at Boston Scientific, IZiel Healthcare, and Better Therapeutics, with a focus on software verification and validation (V&V), quality management systems (QMS), and regulatory compliance for complex medical devices. With a background in engineering and an MBA in Operations Management, Ashwini has facilitated quality operations and strategies for innovative healthcare technologies, implementing robust risk management and quality assurance protocols to ensure patient safety and regulatory adherence. Additionally, Ashwini has contributed to volunteer roles in various organizations, demonstrating a commitment to social impact through digital transformation initiatives.