Tests and Analyses for Safe Medical Devices
Medical tests are conducted to ensure the safety, efficacy, and biocompatibility of medical devices. We offer our services in accordance with internationally recognized standards such as ISO 10993, USP, and EP, and meet all regulatory testing requirements to enable successful market authorization of your products in the medical sector.
Why is Medical Testing Essential for Medical Devices?
Medical devices intended for use on or in the human body must undergo comprehensive testing to ensure that they do not pose a health risk and that any potential risks are minimized. These tests cover a wide range of areas, including biocompatibility, chemical characterization, long-term stability, and storage properties. Furthermore, these tests are required for approval by regulatory agencies such as the FDA or the EMA (European Medicines Agency) and simultaneously ensure the product’s safety throughout its entire lifespan.
With our medical testing services and comprehensive range of offerings, which cover all necessary requirements, we ensure that your product passes all relevant tests and is therefore ready for market launch.
- Analyses and Tests
- Bacterial Endotoxin Tests
- Sterility Test
- Bioburden Test
- Cleaning Validation
Our Testing Portfolio – Comprehensive Solutions for Every Need
We offer a wide range of test types to ensure that the requirements of various medical devices are met. Our services range from in vivo studies and in vitro testing to chemical characterization and biodegradability testing, as well as packaging performance testing and testing for products that generate dust and dirt.
Each of these product testing categories is a key component of the development phase. In addition, they help ensure that your product meets all relevant safety standards.