The MDTL will strive for accreditation to ISO17025, recognized around the world as THE standard for testing and calibration laboratories. Highest level of quality management and technical competency are attributes of an ISO17025 Accredited Laboratory. Moreover, accredited test reports are an integral part of the documents required for submission of medical devices to regulatory authorities like the FDA and NMPA. As such, the MDTL will seek for accreditation with both China (CNAS) and US (A2LA or ANAB) accreditation bodies.
Initially, the MDTL will provide mechanical and material testing services, along with a selection of accredited tests. Expansion of service scope to cover other areas of medical device testing (e.g. electrical and biocompatibility testing) are currently in the planning stage.
With our network of partners and collaborators, we provide technical solutions for your needs, from designing test fixtures and developing new test methods, to assisting in pre-market regulatory approval.