Testing Facility

Biocompatibility & Toxicology

We offer a full range of material assessments using chemical characterization, in vivo and in vitro test services to meet US FDA, EU CE mark Japan MHLW and other international requirements.

Test Services:

• Cytotoxicity

• Genotoxicity

• Hemocompatibility

• Implantation with Histopathology Tests

• Irritation

• ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathway Devices

• Physiochemical USP Plastics Test

• Risk Assessments

• Sensitization

• Sub-Acute and Sub-Chronic Toxicity

• Systemic Toxicity Test (Including Pyrogenicity)

Extractables & Leachables

Our approach combines a technical and analytical expertise, polymer knowledge, understanding of regulatory requirements, all combined in a tailored approach to our customers.

Test Services

• Material Screening Tests

• Physicochemical Plastic Tests