Medical research organization (MRO) NAMSA has opened a new preclinical medical device research laboratory in Shanghai, China.
The organization’s third Asian-Pacific location will enable its clients to launch their product in global markets effectively.
The new 80,000ft² facility will provide a range of laboratory models and analysis tools for preclinical medical device safety and performance evaluations for early-stage R&D development efforts and regulatory submissions.
NAMSA will support clients during all stages of the medical device development process ranging from concept and feasibility testing to post-market surveillance.
It offers consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality services for clients.
NAMSA’s other medical device research laboratories are located in the US, Germany, UK, France and Japan
NAMSA lab services division president Gina Skolmowski said: “Our strong relationship with the China Food and Drug Administration (CFDA), coupled with NAMSA’s proven track record of delivering significant time and cost savings throughout the full medical device lifecycle, will allow our Asian-Pacific clients to further realize efficiencies, including the benefit of closer collaboration.
“The Shanghai laboratory will also allow NAMSA to assist other globally-located clients in their efforts to enter the Chinese marketplace, as well as Asian-Pacific medical device firms wishing to introduce products outside of China.
“By continuing to offer the highest levels of quality and regulatory compliance available today, NAMSA will continue to be a market leader in world class medical device product development services.”