The biological safety (biocompatibility) of medical devices and the related manufacturing processes must be demonstrated to fulfil the regulatory requirements. ISO 10993-1 provides the framework for the biological safety evaluation. A variety of potential toxicological effects must be considered for any device including short-term effects such as irritation, cytotoxicity and hemocompatibility, as well as long-term effects such as sensitisation, chronic toxicity and carcinogenicity.
Together with a network of ISO 17025 accredited test laboratories, Medical Mind can support medical device manufacturers and suppliers by providing the following services:
- Customised strategy development to demonstrate the biological safety according to ISO 10993, based on the risk management
- Biocompatibility testing
- Chemical characterisation, extractables and leachables testing
- Toxicology and risk assessment
- Compilation of the final biological safety evaluation report