Biological evaluation within risk management framework

Left image Medical device configuration and listing of a medical device’s materials of construction (qualitative) and where necessary, the proportion and amount (mass) of each material in the medical device (quantitative)
Left image The physical and chemical characteristics of the various materials of construction and their composition
Left image Any history of clinical use or human exposure data
Left image Any existing toxicology and other biological safety data on product and component materials, breakdown products and metabolites
Left image Test procedure
Left image Medical device configuration and listing of a medical device’s materials of construction (qualitative) and where necessary, the proportion and amount (mass) of each material in the medical device (quantitative)
Left image The physical and chemical characteristics of the various materials of construction and their composition
Left image Any history of clinical use or human exposure data
Left image Any existing toxicology and other biological safety data on product and component materials, breakdown products and metabolites
Left image Test procedure

Biological evaluation pathways

Chemical characterisation
Toxicological risk assessment
Biology test plan
Biocompatibility test
Biological evaluation
Chemical characterisation
Toxicological risk assessment
Biology test plan
Biocompatibility test
Biological evaluation

Chemical characterization

Left image Database of 6,000+ leachables
Left image 10+ years of experience in chemical characterisation
Left image 4,500+ leachables and leachables testing experience
Left image Professional mass spectrometry team
Left image Guaranteed data integrity to meet the requirements of national regulatory authorities
6,000+ 4,500+ 10+
270,000+

Biocompatibility testing

Left image Overall competence testing, including in vivo and in vitro testing
Left image Clinical pathology, autopsy and histopathology, ACVP pathologist, Chinese certified pathologist
Left image 270,000+ biocompatibility studies

Toxicological risk assessment and biological evaluation

Left image
70,000+ toxicological assessment historical data
Left image
2000+ program experiences
Left image
Internationally recognised toxicity prediction software and retrieval data sources
Left image
Experienced team of toxicologists
Left image
High quality reports for global reporting
Left image
70,000+ toxicological assessment historical data
Left image
2000+ program experiences
Left image
Internationally recognised toxicity prediction software and retrieval data sources
Left image
Experienced team of toxicologists
Left image
High quality reports for global reporting

To learn more about medical machinery testing, please contact us