The pre-clinical testing of medical devices at Harlan Laboratories includes the assessment of efficacy and safety, in accordance with national and international standards. Harlan Laboratories provides in vitro and in vivo models for pilot feasibility testing and pre-clinical evaluation of safety and efficacy. Our laboratories are certified according to EN 45011, ISO 17025, GLP and GMP.
- Consulting services
- Toxicological profiling of the materials
- Material characterization by chemical analysis
- Cytotoxicity
- Irritation
- Sensitisation: Kligman
- Genotoxicity
- Hemocompatibility
- Systemic toxicity
- Implantation
- USP class testing