Services

Medical devices:
  • Comprehensive counseling (in all topics mentioned below)
  • Organizing and conducting personalized and group trainings
  • Planning preclinical studies:
    • In accordance with the applicable harmonized standards
    • Or according to individual needs
  • Composition of clinical study documentation:
    • Protocol (investigation plan) writing
    • Compilation of investigator’s manual
    • Data management planning
    • Case report form (CRF / eCRF)
    • Preparation of statistical analysis plan (SAP)
    • Compilation of clinical study report
    • Conducting a full regulatory authorization for a clinical trial
  • Compilation of technical documentation:
    • Clinical evaluation (according to MDD / AIMD and MDR)
    • Compilation of further elements of the technical documentation
  • CE marking
  • Coordination of post-marketing surveillance activities
    • Compiling reports based on a market monitoring plan
  • Consulting on renewal of CE marking, all kinds of related services
In vitro diagnostic (IVD) devices:
  • Performance evaluation test / report
  • Compilation of technical documentation