Vivotecnia has demostrated experience in the preclinical evaluation of the efficacy and safety of medical device, which allows us to design studies that meet the regulatory requirements and are closely focused on the specific needs of your compounds.
We provide a range of safety evaluation and biocompatibility services dor medical devices, including studies designed in accordance with ISO 10993 and USP guidelines:
- In vitro cytotoxicity
- Irritation and skin sensitization studies
- Acute systemic toxicity
- Systemic toxicity and tolerability studies
- Developmental and reproductive testing
ISO10993 to asess the biocompatibility of the medical device.
We have succeessfully tested devices made from plastic, carbon nanotubes sheets, and with different forms, i.e, solids, creams, gels or liquids.
Please contact us to discuss your particular needs and goals.