Biological evaluation within risk management framework
Biological evaluation plan
Biological test/evaluation
Biological evaluation report
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) The physical and chemical characteristics of the various materials of construction and their composition Any history of clinical use or human exposure data Any existing toxicology and other biological safety data on product and component materials, breakdown products and metabolites Test procedureBiological 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 evaluationChemical characterization
Database of 6,000+ leachables 10+ years of experience in chemical characterisation 4,500+ leachables and leachables testing experience Professional mass spectrometry team Guaranteed data integrity to meet the requirements of national regulatory authorities
10+
Biocompatibility testing
Overall competence testing, including in vivo and in vitro testing Clinical pathology, autopsy and histopathology, ACVP pathologist, Chinese certified pathologist 270,000+ biocompatibility studiesToxicological risk assessment and biological evaluation
38,000+ toxicological assessment historical data
2000+ program experiences
Internationally recognised toxicity prediction software and retrieval data sources
Experienced team of toxicologists
High quality reports for global reporting
38,000+ toxicological assessment historical data
2000+ program experiences
Internationally recognised toxicity prediction software and retrieval data sources
Experienced team of toxicologists
High quality reports for global reporting