Safety Testing of Medical Devices
A medical device must be intended to be used for human beings for a medicinal purpose which does not achieve its principal intended action by pharmacological, immunological or metabolic means according to national legislation, e. g. MPG (Medical Device Law in Germany). It needs to be proven that no adverse effects (on cellular basis, local tissue reaction or systemic effects) will be caused by the device after getting into contact with a patient, user or any other person.
Thus, an essential step in the progress of certification of a medical device is the thorough evaluation of biological safety (biocompatibility) as described in ISO 10993 series.
Based on our active membership in different national and international committees we will guarantee that our service is carefully coordinated with the requirements necessary for registration procedures. We can assist you in choosing the appropriate test and we will develop the optimal test strategy for your products.
Whether your need is the biocompatibility testing according to ISO 10993, preclinical studies to determine the performance of the device or microbiological testing within development, production and finished product testing, we will support you with individual testing strategies and study designs to fulfill your needs. In addition, we can offer you further testing strategies for medical devices as well as for raw materials and semi-finished products, e. g. identification and quantification of degradation products (ISO 10993-15), EO residue determination (ISO 10993-7) and USP Plastic Class I-VI testing (USP 87, 88).
In full partnership and coordination with you we will determine the proper procedures for the optimum outcome.
Working in close cooperation with our partner Eurofins BioPharma Product Testing Munich our services for the biological testing of Medical Devices include:
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.
**partially partnered service
*partnered service