IVD Services and Products

IVDR is coming - let's get ready

With the upcoming European In-vitro-Diagnostic Device Regulation (IVDR) the classification on IVD will change. With this all IVD products used in combination require an analytical performance (AP) evaluation.

We support you in preparing your products for the IVDR in the best possible way:

• DiagnosticGrade (in cooperation with the Johner Institut) - The new quality seal for reagents ensures performance and compliance of IVD components. (read more)
  
• Take advantage of our experience to shape your products in compliance with the applicable regulatory requirements.
• Use our CE-IVD approved components (such as Volcano3G® RT-PCR Probe 2x Master Mix IVD) as components in your IVD.

Our IVD services and products support you in meeting regulatory requirements and relieve your laboratory resources. Contact us for more information.