Service

Animal Experiment Study

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.

Team Advantages

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

Laboratory Features

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

Regulatory Compliance

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

Organization Profile

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.

Modern Equipment

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.

Relevant Standards

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

Cytotoxicity test

Genotoxicity test

Blood compatibility test

Implantation test

Sensitization test

Irritation test

Pyrogen test

Systemic toxicity test (acute)

Chronic and subchronic test