Our accreditation - ASCA
WuXi Apptec Medical Device Testing center is the only one lab that is ASCA-accredited for biocompatibility to date in Asia-Pacific area. Utilizing an ASCA-accredited testing lab provides confidence in the accuracy, reliability, and impartiality of the testing results, which is crucial for decision-making, regulatory compliance, and maintaining a competitive edge in the market. The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions, as conformity to relevant standards both reduces regulatory burden and fosters quality.
