PURPOSE
About Us
REGSTALK is more than just a training platform. It is a growing movement focused on making regulatory education more practical, accessible, and genuinely empowering for professionals in the medical device space.
REGSTALK is building a professional community where both aspiring and experienced regulatory professionals can strengthen their expertise, ask questions with confidence, and continue growing through a more engaging and supportive learning environment.
Crafting Compliance, Supporting Growth
Our Mission
Breaking barriers in medical device regulatory education through practical and accessible learning.
Our Vision
To become the global standard for structured regulatory learning that empowers professionals to grow with confidence and advance with purpose.
Our Story
REGSTALK was born from a simple yet powerful realization: most regulatory training is overwhelming, expensive, and disconnected from the realities of day to day work. Our founder, Nivedha Subramanian, recognized that the gap lies not in the lack of information, but in how it is delivered. Random and scattered learning often leads to confusion, making it difficult for professionals to build lasting expertise.
Determined to address this challenge, what began as a small idea quickly grew into a thriving platform where professionals can learn regulations through bite-sized modules, gain practical industry insights, grow at their own pace, and genuinely enjoy the experience of learning.
Meet the Instructor
Nivedha Subramanian
MS, RCC - MDR
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I am Nivedha Subramanian, a biomedical engineer turned regulatory affairs professional, passionate about translating complex medical device regulations into practical and usable knowledge, taught the way I wish someone had explained it when I first started.
My experience spans FDA, Health Canada, and EU MDR regulatory pathways, bringing real industry and compliance perspectives into structured, hands on learning experiences. I am RCC MDR certified, an ISO 13485 Lead Auditor, a Certified Professional Trainer (CPT), a PECB ISO 13485 Certified Trainer, and an active contributor to ISO/IEC medical device standard committees through the Standards Council of Canada(SCC) and the Canadian Standards Association(CSA).
Today, more than 110 professionals have trusted REGSTALK as part of their regulatory learning journey, building lasting knowledge and confidence to support their long-term professional growth — and I would love for you to be next.
Guest Speakers
Gopi Ganesh
Anuradha Gore
