Consultation of a Biostatistician plays a crucial role in the success of medical research and performance studies. Ranging from sample size estimation to statistical analysis, our [...]
There is often confusion as to whether the result of an assay is qualitative or quantitative. This distinction is a key difference for data analysis and misunderstanding can lead to wrong choice [...]
It is easy to generate data but to generate data with high quality is more challenging. Our data management group helps you to give actual meaning to your data while keeping the amount of [...]
Clinical evidence is required for each IVD product regardless of the product class and allows a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), [...]
The guideline for good (clinical) study practice is intended for IVD clinical performance studies. The ISO2091 is referred in the recital (66) of the IVDR-corrigendum from 03.05.2019: “The rules [...]
When planning performance studies for IVDs, there are several standards and guidelines that provide useful advice for study design concepts. However, some even define essential requirements for [...]
A Quality Management System (QMS) is intended to provide a framework for policies, processes, resources, and organization within a company to provide consistent quality for the offered products [...]
The U.S. Food and Drug Administration (FDA) is a regulatory agency in the US responsible for protecting and promoting public health by ensuring the safety, efficacy, and security of: Human and [...]
We perform gap-analysis for our clients. Due to our broad service coverage within the entire IVD life cycle (biomarker validation, IVD development, via market launch and post-market activities) [...]
In the area of medical research and performance evaluation, samples are invaluable. They provide raw material to investigate diseases, to develop treatment and to assess the performance of [...]
