Clinical Performance Studies
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.
Advantages of the product
- Ethics, samples, study and report, all from one source
- Convenient and reliable
- Always according to the latest regulatory literature