ELMAS LLC Information

Elmas Group is a group of companies with regulatory services for medical devices as well as electronics, high pressure equipment, HazLoc. Elmas Medical, a leading regulatory consulting firm with over 30 years of experience, has set industry benchmarks in supporting medical device and IVD companies worldwide with comprehensive regulatory services. Our expertise spans from product registration and independent license holding to importing and providing commercial support. Our team includes a network of medical device specialists based in Russia, India, China, UAE, Europe, USA, Latin America and CIS countries. They are proficient in navigating regulatory requirements, aiding companies in successfully launching their products in various markets. Since our establishment in 1992, we have served over 200 clients around the world, who continue to rely on our regulatory expertise and execution. We have completed more than 10 000 projects in regulatory and certification field. Our range of services includes: - Regulatory consulting - Product registrations for medical devices, IVDs, and pharmaceuticals - In-house testing lab - QMS ISO 13485 certification - Market intelligence - Distributor connections - Certification of electronics, high pressure equipment, HazLoc - Testing in our labs of electronics, high pressure equipment, HazLoc - Production of custom measurement equipment for testing laboratories