The animal experiment is an important part of preclinical study for medical devices and an important bridge connecting basic research and the clinical trial. Tt is expected to obtain new biological and medical knowledge or solve specific problems, and preliminarily verify the safety and effectiveness of medical devices through the animal experiment.
Tigermed-Jyton Medical Device Innovation and Development Technology Service Platform established a nearly 2500 m2 professional laboratory, and has SPF animal laboratories. Almost all animals are from world-renowned suppliers accredited by AAALAC. The strictest standard of the industry is followed for relevant experiments. Safety and daily care of animals conform to and even exceed international standard, to ensure comfort and health of animals. The experiment data are accurate and reliable.
More than 75% team members having a master degree or above
3 deputy senior engineers and above
5 laboratory certified internal auditors (ISO/IEC 17025: 2005)
10+ years’ experience of safety evaluation for medical devices
Working experience in Top 10 national inspection centers
Working experience in CFDA respiratory pharmacology laboratory
Experience in drug safety evaluation of Chinese Academy of Sciences
Working experience in world-renowned device/technical service manufacturers
Comply with AAALAC and FDA accreditation standards and the strictest standards of animal welfare
Accredited by CNAS and CMA
First-class customer service
Efficient experiment arrangement and high-quality experiment report
Professional project management
GLP requirements of FDA, OECD . and CFDA are Fully complied with.
The supporting experiments and project design comply with guiding principles of global regulations
The experiment design complies with guiding principles of different institutions based on customer requirements
Standardized design, HEPA-filtration, computerized early-warning monitoring and control
The animal house of 800+ m2 can accommodate laboratory animals such as New Zealand rabbits, guinea pigs and hamsters.
The rodent house uses the SPF barrier system and meets specific requirements of FDA and CFDA.
The facility is equipped with the outage emergency system and the standby support system for the water treatment system.
The organization provides customized service for long-term clients.
First-class equipment conforming to industrial standard
Advanced electronic information recording and storage
Fully-validated electronic detection systems are used to realize environment control and monitor laboratory equipment and safety.
GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use--Part 2: Biological test methods
GB/T 16886.4-2003 Biological evaluation of Medical devices--Part 4: Selection of tests for interactions with blood
GB/T 16175-2008 Biological evaluation test methods for medical organic silicon materials
YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry--Part 2: Test method--Acute systemic toxicity: intravenous path
Chinese Pharmacopoeia 2015 edition, Undue Toxicity Test
Medical Device Testing Services Provided:
Biological risk assessment and biocompatibility test
Blood compatibility test
Systemic toxicity test (acute)
Chronic and subchronic test