We can offer a complete range of services for the biological evaluation of medical devices according to ISO 10993 and USP requirements.
Biocompatibility Testing of Medical Devices
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Subchronic Toxicity
- Genotoxicity
- Pyrogenicity
- Implantation
- Hemocompatibility
- Chronic Toxicity
Microbiological Testing of Medical Devices
- Test for Sterility
- Endotoxins
- Bioburden
- Test for Specified Microorganisms/Microbial Limit Test
- Test for Antimicrobial Preservation
- Validation of Test Methods/Suitability Tests
- Identification of Microorganisms
- Test for Antimicrobial Efficacy
- Evaluation of Reusables for the intended Reprocessing Procedure (Cleaning, Disinfection, Sterilization)
- Environmental Monitoring
- Process Water Testing
- Analysis of Bioindicators
- Sterilization Processes: Microbiological Studies within Performance Qualification
- Validation of Depyrogenation Processes
Additional Services
- Functional Implantation studies (bone, dental, hemostasis, cardiovascular…)
- Identification and quantification of degradation products (ISO 10993-15)
- Packaging validation (ISO 11607)
- EO residue determination (ISO 10993-7)
- OphtaImic Implants – Intraocular lenses (ISO 11979-5)
- Dental Implants (ISO 7405)
- USP Plastic Class I-VI (USP 87, 88)
- Various Test Designs according to ISO standards, USP and Ph. Eur.