Accurate diagnostics for confident decisions - in vitro diagnostics
In vitro diagnostics (IVDs) are playing an increasingly important role in modern medicine. Legislators have also recognised this and now regulate international IVD approvals to a considerable extent.
Whether for laboratory analysis, point-of-care testing or molecular diagnostics, the demands for safety, accuracy and regulatory compliance are increasing.
From development to clinical performance and IVDR approval. We support you with our in-depth expertise.
We aim to strategically navigate regulatory hurdles, generate scientifically sound evidence and ensure that your product is successfully marketed.
For the success of your IVD solutions – regulatory compliant, scientifically sound, market driven.
Accurate diagnostics for confident decisions - in vitro diagnostics
In vitro diagnostics (IVDs) are playing an increasingly important role in modern medicine. Legislators have also recognised this and now regulate international IVD approvals to a considerable extent.
Whether for laboratory analysis, point-of-care testing or molecular diagnostics, the demands for safety, accuracy and regulatory compliance are increasing.
From development to clinical performance and IVDR approval. We support you with our in-depth expertise.
We aim to strategically navigate regulatory hurdles, generate scientifically sound evidence and ensure that your product is successfully marketed.
For the success of your IVD solutions – regulatory compliant, scientifically sound, market driven.