In Vitro Diagnostics
The Performance Study aims to establish or confirm the analytical and/or clinical performance of an IVD to achieve the manufacturer’s intended purpose.
- Analytical performance refers to the ability of a device to correctly detect or measure a particular analyte.
- Clinical performance refers to the obtention of results that correlate with a particular clinical condition or physiological or pathological process or state in accordance with the target population and intended use.
How can DDR help?
- DDR can help the manufacturer in the design of the Performance Studies that support the intended purpose of the IVD.
- DDR will introduce you to well-renowned Contract Research Organizations (CRO) that specialize in the field of devices.