We are dedicated to the project at hand and have the expertise to quickly address all your regulatory needs. Let us take care of regulations so you can focus on what you do best.

About Us

What is Elexes?
  • Founded by a team of professionals with over 20 years of experience in Regulatory affairs, Elexes is dedicated towards bringing safe and effective healthcare technologies to the market and ensure that the existing devices are in compliance.
  • We comprise of professionals who are RAC certified by RAPS, Certified Quality Auditor by American Society of Quality, and Certified Lead Auditor for ISO 13485 by BSI.
  • Specializing in Medical Devices, IVD and Combination Products, we have developed into a trusted online partner offering a wide range of compliance and market-access services, with an expertise in regulatory submissions, post market surveillance, clinical writing and quality systems. Over the past years, we have served more than 50 clients, both national and international, assisted with several FDA submissions, CE marks, ISO 13485 certifications, CMDCAS certifications and offered numerous other regulatory and quality services.
  • Get in touch with us and we can address your regulatory and quality requirements pertaining to the US, EU, Canada, India and markets all around the world. Let’s work together and give the best to the society!