Medical Device Flyer
The pre-clinical testing of medical devices at Harlan
Laboratories comprises the assessment of efficacy and safety, in
accordance with the Council Directive 93/42/EEC of June 1993 and
ISO 10993-1 "Biological evaluation of medical devices part 1;
guidance on selection of tests".
Harlan Laboratories provides in vitro and in
vivo models for pilot feasibility teating and pre-clinical
evaluation of safety and efficacy. We can develop customized
experimental models for specific applications. Typically,
appropriate steps for biological assessment of medical devices
consist of:
- In vitro assessment of cytotoxicity and
genotoxicity
- In vitro and in vivo assessment of efficacy
and feasibility of intended application
- In vivo safety assessment according to standard
guideline procedures
Services
- Toxicological profiling of the chosen materials
- Material characterisation, biological and toxicological
evaluation
- Biocompatibility testing according to ISO 10993
- Strategic planning of study program
- Genotoxicity, carcinogenicity, reproductive toxicity
- Hemocompatibility, static and dynamic systems
- Cytotoxicity
- Implantation, i.e. vascular stents, vascular grafts,
bioresorbable polymers, osseous tolerability, histopathology
- Determination of ethylene oxide sterilization residuals
- Determination of material degradation, irritation and
sensitization
- Systemic toxicity, i.e. acute, subacute, subchronic,
chronic
- Determination of degradation products from polymers, ceramics,
metals and alloys
- Material characterisation
- Toxicokinetics
- Risk assessments and expert statements