ICS performes Clinical Perfomrance Studies for you!

Dr. Karl Lewin Günther

Head of in.vent Clinical Services +49330255199550 E-MAIL SENDEN

Clinical Performance Studies

in.vent Clinical Services

A Clinical Performance Study assesses the ability of a device to deliver results that correlate with a certain clinical condition. Strictly following the IVDR and ISO 20916:2019 we will plan, conduct and report this study for you: - Application to an ethics committee - Sample procurement - Clinical Performance Study Plan according to ISO 20916 and IVDR, annex XIII, part A - Study site recruitment and monitoring - Study conduct - Statistical analysis - Clinical Performance Study Report according to ISO 20916 and IVDR, annex XIII, part A While our service comprises the whole process of Clinical Performance Studies from A to Z, you may freely choose which particular services you need. We will adapt our quotation accordingly.

Vorteile des Produkts

  • Ethics, samples, study and report, all from one source
  • Convenient and reliable
  • Always according to the latest regulatory literature