Industry Partners
Profile Facility Facility
Regulatory consulting and testing

It is a regulatory consulting, testing and audit support firm. It offers services like Implementation and management of Quality Systems compliant with FDA QSR and ISO 13485, Document preparation to comply with Design Controls, Audits to assess compliance with FDA Quality Systems Regulations and ISO 13485 and Clinical study protocol development.  Ms. Divya Ganapathy is the CEO and founder of Regulatory1 and Theone Fitness Studio. She is a certified lead auditor from RABQSA, qualified Internal auditor, with expertise in CE marking and 510(k) documentation. She is trained in biocompatibility and packaging validation studies for medical device in MDT, Germany. She is guiding BETiC, IIT Bombay for ISO 13485 certification process
Online Portal for Device Registration in India- Mandatory
Importance of Applying Usability Engineering to Medical Devices