Biological Evaluation within a 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 Characterization
Toxicological Risk Assessment
Biological Test Plan
Biocompatibility Test
Biological Evaluation Chemical Characterization Toxicological Risk Assessment Biological Test Plan Biocompatibility Test Biological EvaluationChemical characterization
Access to a database of over 6,000 extractables and experience testing over 4,500 leachables, supporting comprehensive chemical characterization. Over 10 years of experience in chemical characterization for global medical device submissions. Professional structure elucidation team supporting accurate identification and analysis of device materials. Expertise in leachables testing and mass spectrometry for reliable data generation. Guaranteed data integrity to meet national and international regulatory requirements.
10+
Biocompatibility testing
GLP-, ISO 17025-, and ASCA-accredited laboratory, supporting globally recognized quality systems and regulatory compliance. Comprehensive in vivo and in vitro testing, including cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, hemocompatibility, genotoxicity, and implantation studies. Conformance with the latest ISO 10993 standards. Experienced pathologists and toxicologists supporting accurate interpretation and reporting. Over 270,000 biocompatibility studies conducted, providing robust historical data for regulatory submissions.Toxicological risk assessment and biological evaluation
Over 38,000 historical toxicological assessments.
Experience from over 2,000 programs.
Use of internationally recognised toxicity prediction software and data sources.
Experienced team of toxicologists.
High-quality reports supporting global regulatory submissions.
Over 38,000 historical toxicological assessments.
Experience from over 2,000 programs.
Use of internationally recognised toxicity prediction software and data sources.
Experienced team of toxicologists.
High-quality reports supporting global regulatory submissions.