Company BW, LLC is the largest regulatory affairs agency for registration of medical device and IVD product in Russia, for 2019 was ranked on 6th place (after Abbott, Bio-Rad, Medtronic, Roche) and for 3 past quarters of 2020 BW, LLC holds 1st place by quantity of registered products (official statistics of Rosdravnadzor).
There are 2 main departments with 30 employees in frame of company structure- medical device registration and IVD product registration department with wide range of technical expertise.
We have successfully obtained more then 200 registration projects from 1st up to 3rd risk class in frame of new regulation.
Company BW, LLC provides both type of services: registration in frame of national registration system and single market in frame of Eurasian Economic Union (ARM, BLR, KAZ, KYG, RUS).
Company BW, LLC also provides independent authorized representative service for manufacturers worldwide.
Main principle of our work is Product. All in certification services, all in approvals starts from product: product characteristics, product properties and intended use. We support: consulting for QMS; development of risk management file and clinical evaluation, technical file and specific testing for different type of devices.
So for us – product is the first. We work for you, we do it everyday.
Test-ME team – chemical indicators for sterilization and temperature indicators for pharmaceutical industry.