Yashaswini Patwardhan

Founder Consultant US & EU

Yashaswini Patwardhan started her journey in the medical device industry 17 years ago as an intern in Los Angeles and graduated with an MS in Biomedical Engineering from the University of Southern California shortly after. The intern position led to a job opportunity in Buffalo, New York in 2006, where she worked with both small and large medical device manufacturers within Western New York. During these 8 years, she gained a solid footing in 21 CFR Part 820 quality management systems (QMS) requirements and 510 (k) market authorization pathway.

When an opportunity arose to join a consulting project in 2014, she engaged fully. This decision was truly life changing, since it meant working on a project in Germany alongside other consultants. The 3.5 years there grew her professional network internationally and further enhanced her knowledge and experience in FDA QMS remediation and eventually led to her first project tackling CE marking. With the introduction of MDR around that time and its coming into force in May 2021, it has been a whirlwind of activity assisting clients with MDD-MDR transition both in Europe and the USA, while also being engaged in FDA enforcement action related QMS remediation. Amid all this, in August 2021 Yasha acquired an Executive MBA from the Quantic School of Business and Technology.

Your exceptional support during the MDR project is invaluable. Your commitment to understanding our product families and processes ensures that our needs are met. Your proactive approach in addressing LoQs and identifying areas for improvement is commendable. The RA EMEA Team deeply appreciates your dedication.
Johnson and Johnson Vision team
Your expertise shines through in every interaction. Your willingness to collaborate and share insights elevates our team. Your attention to detail and commitment to excellence make the MDR transition smoother. We’re grateful for your contributions.
Johnson and Johnson Vision team
Your technical acumen is a game-changer. Your adaptability to our context and your thoughtful proposals for addressing LoQs demonstrate your brilliance. Your cultural insights enrich our team. Thank you for being an asset.
Johnson and Johnson Vision team
Your impact extends beyond projects. Your dedication fosters a positive work environment. Your ability to bridge expertise with cultural understanding is remarkable. We value your professionalism and kindness.
Johnson and Johnson Vision team
Your multifaceted contributions resonate deeply. Your unwavering support during the MDR transition sets a high standard. Your cultural insights foster camaraderie. We’re fortunate to have you—a true team player.
Johnson and Johnson Vision team