Definition
In-vitro diagnostics are medical devices used to analyze human body materials, such as tissues or fluids, outside the body to obtain information about a person´s health condition.
Speciality
A particular challenge with in-vitro diagnostics lies in the extensive requirements for quality and safety standards. These products are subject to strict approval and labeling regulations, which require comprehensive documentation and CE marking. Additionally, the development and manufacturing of in-vitro diagnostics require a deep understanding of medical, biochemical and molecular biology principles.
We specialize in ensuring compliance of regulatory requirements. A key aspect is the producing of technical documentation, which includes all information regarding the safety perfomance of the product. This documentation is essential to demonstrate compliance of legal regulations and to obtain succesful approval.