ABSTRACT
Animal research of medical devices/medical materials is an essential part of preclinical safety and efficacy evaluation. Many questions should be taken in considerations when it comes to design and conduction animal research of medical devices/medical materials because of its uniqueness. This kind of research has widespread studying objects while has no universal standard method, and should be designed case-by-case. This article is aimed at serving as a reference for sponsors and researchers when performing preclinical safety and efficacy evaluation of medical devices/medical materials.
Subject(s)
Animals , Animal Experimentation , Equipment Design , Equipment and SuppliesABSTRACT
Biological tests of medical devices is an important part to evaluate its biological safety. Good quality management of the test is a powerful guarantee to ensure the authenticity, integrity and reliability of the test results. This paper is based on the biological tests of medical devices, compares GLP and ISO/IEC 17025 which is widely used in China medical device testing institutions, describes the implementation of the GLP reference points to strengthen the quality management of biological tests of medical devices under the ISO/IEC 17025 system, to provide reference for quality management of medical device testing institutions.