完美(中国)体育官方网站-在线入口

Based on Total Quality Management (TQM), risk management and regulation requirements of medical devices, we integrate innovative thinking in our R&D management and adopt advanced Product Development Process (PDP) of medical devices. By virtue of the refined R&D management system and the efficient medical device quality management system, we implement systematical management on R&D personnel, R&D facilities, R&D projects, and R&D process assets etc., and we also implement quality control over the entire project life cycle of medical devices to ensure our R&D and innovation activities are efficient, systematic, and standardized.

We highly respect intellectual property rights, and strictly implement intellectual property analysis, early-warning, and risk monitoring over the whole life cycle of our products. As of 30 June 2023, over 1,900 valid patent applications have been filed, of which more than 800 patents have been registered in worldwide.

With professional teams in clinical operation, project management, medical affairs and clinical assessment, we work closely with authoritative clinical centers around the world. We fully consider clinical needs of different countries and regions, cooperate closely with industry experts, fully allocate resources, and formulate clinical research strategies. The existing clinical projects are progressed in China, United States, Europe, South America, and Southeast Asia to actively promote pre-market and post-market clinical studies of our innovative products, providing  evidence-based medicine and demonstrating the safety and effectiveness of the devices.

With an experienced global regulatory affairs team, we focuse on regulatory compliance management over the entire lifecycle of our products. The team also plays a significant role in the formulation of product development strategies from the perspective of optimizing the product registration path, to facilitating the commercialization of our products in the global market. To date, our innovative products have been successfully registered in over 100 countries and regions around the world.

We have advanced research facilities for the development of our medical device products. We have built CNAS qualified and CMA recognized laboratories, with professional technical capabilities in physical properties test, chemical analysis, biomechanical test, material characterization, failure analysis, biocompatibility evaluation, animal experiment, pathological study, and etc.