WuXi AppTec Reports Record Results in 2022
2023-03-22
About Us
WuXi AppTec Medical Device Testing business has operating entities in China and the United States. The Department provides an integrated testing platform for medical devices which includes biocompatibility test, chemical characterization, toxicological risk assessment, biological evaluation, large animal research, microbial test, etc. The testing platform is composed of the outstanding technical and management team in the world. It has established China Medical Device Testing Center in Suzhou Wuzhong District based on international FDA GLP, OECD GLP, CNAS, ISO13485, A2LA quality management standards, China CMA and AAALAC operation standards. WuXi Clinical has ability to provide clinical studies and product registration services for medical devices from phrase I to IV. WuXi MedKey has rich experience in operating more than 200 medical device clinical trials and working closely with 1000 Chinese hospital clinical trial centers.
Business Introduction
Large animal experiment
Pathology Services
Chemical testing
Toxicological risk assessment
Microbiological test
Biocompatibility
Biological evaluation
Product registration
Large animal experiment
News
2023-03-01
The China Food and Drug International Exchange Center
2023-02-20
WuXi AppTec Plans to Build a New Site in Singapore, Better Serving Global Partners and Advancing Healthcare Innovation
MD Cloud Classroom
Academic Sharing
Brain implantation test of medical devices
2021-11-23
The international organization for stand...
Have we identified the extractables and leachables (E & L) of medical devices correctly?
2021-10-10
With the promulgation and implementation of the new version of iso10993-18:2020 on the chemical characterization of medical device materials in the risk management process and the public solicitation of cmde in June 2020 for the guiding principles for the review of the establishment of evaluation methods and characterization techniques for unknown leachables of medical devices (Exposure Draft) Opinions issued a notice that combining the chemical characterization and toxicological risk assessment of medical devices with the biological evaluation of biocompatibility test results has become a new trend in the development of biosafety evaluation of medical devices. E & L research in medical devices will soon become an indispensable part of the whole process of product R & D, registration and application. Due to the complex material composition and production process of some medical devices, the types and quantity of E & L produced are extremely large. It is estimated that there are tens of thousands of kinds, and the content of these chemicals in the extraction solution is small, which poses a big problem for the identification of chemicals. In the process of E & L research using various technologies of chemical characterization of medical devices, mass spectrometry, especially high-resolution mass spectrometry, can infer the molecular formula of compounds by using accurate molecular weight, which provides a practical idea for E & l work. At the same time, there are also some difficulties in the structural analysis of chemical substances based on mass spectrometry. If there is no participation of professional mass spectrometry analysts in the implementation process, the identification work is very prone to errors.
WuXi AppTec is committed to building a global R&D empowerment platform for medical devices!
