About Me
Hi, I am Saloni!
Passionate about bridging the gap between regulatory compliance and innovation. With a strong background in risk assessment, compliance frameworks, and process optimization, I help teams navigate the complexities of developing and maintaining compliant SaMD in a rapidly evolving regulatory landscape..
My Journey
Throughout my career, I have worked on medical device software and SaaS platforms, ensuring they comply with FDA, ISO 13485, IEC 62304, ISO 14971, GDPR and many more standards. My expertise lies in establishing risk management processes, conducting regulatory assessments, and ensuring alignment with industry best practices.
I excel at identifying potential risks early in the development process and implementing structured, proactive risk mitigation strategies. My approach involves close collaboration with cross-functional teams, including engineering, regulatory affairs, and quality assurance, to ensure that compliance is seamlessly integrated into the software development lifecycle.
Beyond Work
While I thrive in the structured world of compliance, I equally love exploring the unknown and taking on new challenges. I find joy in:
🏔️ Hiking & outdoor adventures – Exploring new trails and enjoying nature’s beauty
🏊 Swimming – A relaxing yet invigorating way to recharge
✈️ Travel & new experiences – Immersing myself in different cultures and perspectives
🎭 Solving puzzles & escape rooms – Because who doesn’t love a good challenge?
📖 Continuous learning – From AI and ML to the latest regulatory changes, I’m always curious to expand my knowledge
I believe that growth comes from stepping out of your comfort zone, whether it’s in career challenges or personal adventures.