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WELCOME TO REGSTALK

Welcome to RegStalk - Your go-to hub for growing your career with confidence. Whether you're just starting out or aiming for your next big move, we’re here to fuel your growth with affordable, practical, and action-packed training on key medical device regulations.
No more gatekeeping. No more overwhelm. Just real support, real results,
and a whole lot of growth.
Let’s do this together one smart session at a time.

 

Our mission: To make upskilling super easy, totally accessible, and kind to your wallet  with bite-sized modules built for your busy life.

"Crafting Compliance, Supporting Growth"

Nivedha Subramanian

NIVEDHA SUBRAMANIAN
MS, RCC - MDR

Hey there! I'm Nivedha Subramanian, a biomedical engineer turned regulatory affairs specialist with 6+ years of global experience in the medical device industry. I’m RCC-MDR certified, an ISO 13485:2016 Lead Auditor, Lean Six Sigma trained, and hold a Master’s in Regulatory Affairs. I’ve worked extensively on FDA 510(k)s, Health Canada MDLs, EU MDR documentation, and global QMS audits bringing a blend of regulatory strategy and hands-on execution.
 

 My sweet spot? Taking complex regulatory topics and turning them into clear, engaging, and applicable content. That’s what drives everything at RegStalk to move beyond textbook-style training and bring real-world, application-driven learning to professionals through my programs. 

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