Lack of internal toxicologists, uncertainty about when and how to test, and the costs of in vivo methods, especially when animal use and veterinary oversight are involved, can delay approval and inflate budgets. That’s why more organisations are turning to in vitro alternatives. Validated, reproducible, and reliable, these methods often offer improved predictability for human response. They also support faster decision-making, clearer regulatory pathways, and a more ethical approach to product development.

At Eurofins Medical Device Services network of laboratories, our in vitro biocompatibility testing services are fully aligned with ISO 10993-1. You will have access to a team of scientific experts and toxicologists committed to evaluating safety efficiently, ethically, and accurately. We are committed to the 3Rs principles of Replacement, Reduction, and Refinement in animal testing, by offering robust alternatives that meet global regulatory expectations.

Our testing for:

• Acute systemic toxicity, skin and eye irritation, and skin sensitisation
• Repeated-dose toxicity, carcinogenicity, and reproductive toxicity
• Local tolerance testing using reconstructed human epithelium
• Performance testing such as barrier efficacy, wound healing, and whitening tests
• Surface modification analysis including osteoblast and fibroblast proliferation

Our compliant in vitro laboratory in Italy houses some of the most advanced technology in the industry. We support both standardised testing and custom assay development, partnering with clients to select the most suitable method for their materials and applications. We also collaborate closely with regulatory agencies, ensuring all studies meet the latest requirements.

Study Types for Screening Purpose:

in silico Safety Modeling

• Structure activity relationship by computerized models (Multiple softwares available)

Eye Irritancy

• Bovine corneal opacity and permeability test (BCOP; OECD 437)

Skin Irritation

• Reconstructed human epidermis model (OECD 439, ISO 10993-23)

Skin Sensitisation

• In vitro: KeratinoSens (OECD 442 D)
• In vitro: Activity of dendritic cells – h-Clat

Local Tolerance

• Oral mucosal irritation using human reconstructed oral epithelium
• Vaginal epithelial irritation using human reconstructed vaginal epithelium
• Bladder epithelial irritation using human reconstructed bladder epithelium

Performance Testing

• Barrier efficacy test (human skin model)
• Lenitive efficacy test (human skin model)
• Wound healing efficacy (human skin model)
• Whitening efficacy (human skin model)

Medical Device Surface Modification

• Osteoblast Cell Line Proliferation Test
• Fribroblast Cell Line Proliferation Test