Based on Turthful and composed of several senior research, technical, and quality personnel with senior background in the pharmaceutical industry and consultantion, Abmed is a consulting company focusing on multi-country medical devices regulation registration services. For more than 10 years, it has served more than 1000 medical customers and nearly 100 listed companies. Moreover, it has subsidiaries in medical technology consulting, testing technology services, medical clinical research and others, located in Suzhou, Shenzhen, Qingdao, Hangzhou and other places.
Business scope：
It provides CE-MDR/IVDR, FDA 510K, ISO13485/QSR820, NMPA/GMP/GSP of China NMPA, MDSAP and registration in its five countries, but also Russia, South Korea, Singapore, Thailand and other countries. EAR, FDA, FSC free sales certificate service. Its one-stop service aims to meet the requirements of different national regulatory authorities and to provide professional technical consulting services for customers.
Our advantages:
1. More than 10 years of medical device certification consulting service experience
2. Hundreds of product experiences and nearly a thousand successful cases
3. Professional group service
4. Covering testing consulting, regulatory consulting technology, etc
5. Pre-market regulatory consultation and post-market registration services
