RAMED, Your Competitive Advantage
RAMED is the first company in China jointly established by world known medical
device technological service experts and regulatory affairs experts, and is specialized in new medical technology
transfer, product incubation and regulatory affairs service. The aims of the company are to provide the medical
device research institutions and the industry in the world (mainly China and USA) with industrialization operation
and high quality professional regulatory compliance solution covering the entire life cycle of the product.
RAMED experts from China and other countries, with more than 20 years of professional experience, will deliver
an integrated technical implementation and regulatory compliance process covering GMP plant establishment,
quality system management, R&D verification, clinical trial, product registration and post market management,
etc., to those who have products to be manufactured, marketed and used in China; and provide regulatory service
like the USFDA pre-market approval and GMP management to those who have medical devices to be exported to the
US. In addition, we also provide regulatory risk assessment for investment and acquisition.
RAMED is currently the only BSI ISO 13485 certified service in China for professional consultancy services of
regulatory affairs and quality management for medical devices including IVDs. RAMED has copyright for several
SOPs established with 20 years professional experience to ensure high quality of its service.
RAMED has set up affiliated offices in Beijing, Shanghai and Boston.
RAMED current existences are:
RAMED (Beijing) Medical Technology Co.,Ltd
Shanghai RAMED Medical Technology Co.,Ltd。