ICS – in.vent Clinical Services

ICS is the newest expansion of our service portfolio. We have harnessed our 20 years of expertise in diagnostic studies to conceive a new level of IVD-services: A complete all-round package covering every step of diagnostic assay validation, including all performance studies, study protocols, and reports.

Place your trust in our expertise: We know which and how many samples will be required for the validation of your assay. We will perform, manage, and document the analytical and clinical validation in an IVDR-compliant manner. We will get your assay CE-certified.

ICS was founded with regard to the major challenges for the European diagnostics industry that arise with the implementation of the EU regulation 2017/746 on in vitro diagnostic medical devices (IVDR 2017/746). It is our goal to help global IVD developers and manufacturers to master this challenge.

Therefore, we offer a one-stop service covering every relevant step of the IVD validation and marketing process:

  • Performance Evaluation Plan
  • Sample Procurement & Processing   
    • Communication with Ethics Committee & Legal Authorities   
    • Study Site Initiation & Monitoring   
    • Informed Consent
  • Study Protocols
  • Analytical Performance Studies
  • Clinical Performance Studies
  • Data Management 
  • Biostatistics
  • Performance Evaluation Report
  • CE-Marking
  • Post-Market Surveillance