About
About Sara MedTech
Sara MedTech was founded by seasoned regulatory and quality professionals with deep experience in US FDA, EU MDR, CDSCO, and ISO standards. Our core approach is scientific advisory and regulatory approvals, ensuring that every submission, audit, and compliance activity is backed by strong scientific rationale and robust technical documentation.
Our mission is simple: to provide clear, practical, and scientifically sound regulatory pathways that accelerate your product's time-to-market without compromising quality or safety.
01What Sets Us Apart
- Hands-on expertise in dental, orthopedic, spinal, IVD, SaMD, and hospital/consumer devices
- Scientific advisory–driven regulatory strategy and submissions
- Proven track experience with 510(k), CE Marking, and CDSCO registrations
- Integrated support for QMS implementation (ISO 13485, MDSAP)
- Training to the clients and awareness creation within manufacturing unit
- End-to-end project management from concept to commercialization
02Lead Consultant
Rahul Raveendran
Lead Consultant & Certified ISO 13485 Auditor
With 10 years of experience in New Product Development (NPD) and New Product Introduction (NPI) for global markets, Rahul brings deep expertise in medical device regulatory affairs, quality management systems, and international compliance. As a certified ISO 13485 auditor, he leads Sara MedTech consulting engagements with a focus on practical, audit-ready solutions.
- ISO 13485 Certified Auditor
- NPD / NPI
- Regulatory Affairs
Ready to accelerate your regulatory pathway?
Tell us about your device and the markets you are targeting. We will come back with a clear view of the pathway and what it takes.