Regulatory tests

MEDICAL DEVICES TESTING

Porsolt's vast array of models and technical capabilities that have been acquired and validated over many years, enable us to provide testing services for Medical Devices that follow ISO and OECD guidelines and include in vitro and in vivo models for sensitization, toxicity and safety.

Regulatory tests

Medical devices are evaluated for their biocompatibility as described in ISO 10993. This is the accepted international standard and is used in accordance with national requirements such as "The United States Pharmacopeia".

The range of medical devices is very diverse. The forms of devices we can test include powder, solid devices, plastic, metal, ceramic, creams, gels, liquids, fabrics, glues and adhesives.

Specific tests are recommended by the standards for each device type to evaluate the biocompatibility of medical devices.