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.