Navigating Regulatory Challenges in Digital Transformation for Medical Devices: A Conversation with Quality and Regulatory Expert Divya Gowdar

In this installment of the Life Sphere podcast, Kathleen Brunner, the host, engages in a professional conversation with Divya Gowdar, a seasoned Quality and Regulatory Professional with a broad range of experience across multiple product portfolios in both small and large Medical Devices and Combination Product Organizations.

Divya's unwavering commitment to enhancing patients' quality of life propelled her to establish NubGenix Consulting, which is passionately dedicated to making a difference in the quality of patients' lives. Kathleen and Divya delve into the merits of taking a proactive approach to regulatory requirements, emphasizing the importance of quality and getting it right the first time.

Furthermore, the discussion highlights an exceptional, cost-free resource that is available to assist firms in managing regulatory requirements while also exposing the challenges and opportunities of digital transformation in life sciences, including the use of Artificial Intelligence (AI) to provide solutions to patients more quickly.

Divya's philanthropic mindset and dedication to giving back are also discussed, with a particular emphasis on the significance of promoting science and math education early on in the schooling of young girls and encouraging them to pursue careers in STEM.

Divya Gowdar, the CEO and founder of NubGenix Consulting LLC, has a demonstrated track record of achievement and successful contribution in quality management systems, end-to-end product development lifecycle, risk and process management, quality compliance, and manufacturing operations in compliance with US FDA and other international regulations. Her firm offers services such as the development and implementation of Quality Management Systems (QMS), establishing regulatory, quality, and compliance strategies for product launch, and streamlining workflows such as Audit and Inspection Management, Post Market Surveillance, and more.