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
Qualification measures:

Growing Organisation; Adaption of Qualification to new market demands, project areas and fields of production

To achieve the goal, that invent persist at the international market, qualification for current and new employees were conducted as follows:

  • training in online-marketing,
  • in contract law and
  • in business basics for executive leadership with scientific background.

New employees acquired competences in the fields of:

  • data protection,
  • medical devices advice,
  • internal auditing,
  • performance assessment of in-vitro diagnostics as well as
  • project management

In the field of production, knowledge of macro programming was gained for digitization.

The measures were funded through the European Social Fund and the state of Brandenburg for the period 2019 – 2021.