RAMED, YOUR COMPETITIVE ADVANTAGE ! Strong Professional Background - RAMED is co-founded by regulatory affairs experts who ever worked for BD, Thermo Fisher Scientific at leading position in China mainland. - All members of RAMED come from global leading medical device companies, and possess abundant professional knowledge and experience in regulatory affairs. - Average 14 years RA/QA experience for medical devices. What We Can Professional Help - Pre-market approval (CFDA registration, Clinical Trial in China, GMP, R&D, GSP, Compliance Management) - New project evaluation for regulatory risk and strategy. - Post-market surveillance (CFDA medical device distribution license, adverse event and recall, labeling and Chinese manual review and approval, CFDA advertisement review and approval) - Regulatory compliance assessment for acquisition. Solution with 20 Years Experience - CFDA registration cover a variety of products made in the US , Europe and Asia Pacific. - Rich experience in compliance management for more than 300 distributors in China. - Have abundant cross-cultural working experience. - Result-oriented SOPs with copyright of RAMED. - Risk prevention based management through each step of our work. High Quality Service - Our service is certified with BSI ISO13485. - Each project is strategized and conducted by 5 experts with more than 10 years professional experience, to ensure the solution is feasible, with low cost and short cycle time as possible. - Our service is integrated to the product entire life-cycle. Our Service Ethic and Mission Our purpose is to help people live healthy lives through promoting the development of the healthcare industry with our efforts to provide help to more companies with our practical working experience and knowledge that is diligently accumulated in our previous work in the global leading companies. DEVOTION, SPECIALTY, STANDARD is our value propositions to be delivered !