MEDICAL DEVICES TESTING

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.

Want to conduct the biological evaluation of your medical devices?

We have in vitro and in vivo capabilities, and expertise, including models for irritation, sensitization, toxicity and safety, that conform with ISO and OECD guidelines for medical device development.

CYTOTOXICITY

IN VITRO
MTT colorimetric cell viability assay L929 cells TOX 18
Neutral Red colorimetric cell viability Assay 3T3 cells TOX 19

GENOTOXICITY

IN VITRO

Micronucleus assay

CHO-K1 Hamster cells

In development

Mouse Lymphoma assay

L5178Y TK+/-- cells

In development

IN VIVO
Mammalian erythrocyte micronucleus assay Rat TOX 17

IRRITATION

IN VITRO
Reconstituted human epidermis irritation assay Episkin TOX 21
IN OVO

HET-CAM (Hen’s Egg Test Chorio Allantoic Membrane)
alternative to occular irritation assay

Chicken egg TOX 24
IN VIVO
Skin irritation test Rabbit TOX 3
Acute dermal irritation (topical application) Rabbit TOX 22
Intradermal reactivity test (intracutaneous injection) Rabbit TOX 16

TOXICITY

IN VITRO
Acute systemic toxicity (or repeated doses)
alternative to embryotoxicity in mammals
Chicken egg TOX 23
IN VIVO
Acute systemic toxicity Mouse - Rat TOX 11
Repeated doses systemic toxicity Mouse - Rat TOX 12

SKIN SENSITISATION

IN VIVO
Local Lymph Nodes Assay (LLNA)
Mouse TOX 14
Guinea-Pig Maximization Test (GPMT) Guinea-pig In development