Medical Devices

We offer services for biocompatibility / toxicity related testing of Medical Devices as per ISO guidelines.

ISO guideline             Studies
ISO 10993 Biocompatibility
ISO 10993- 1:2009 Evaluation and testing in the risk of management process
ISO 10993-3 Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4 Selections of tests for interactions with blood
ISO 10993-5 Tests for in vitro Cytocompatibility evaluation
ISO 10993-6 Tests for local effects after implantation
ISO 10993-10 Tests for irritation and delayed-type hypersensitivity
ISO 10993-11 Tests for systemic toxicity
ISO 10993-16 Toxicokinetic study design for degradation products and leachables
ISO 10993-20 Principles and methods for immunotoxicology testing of medical devices