Performance Study

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.

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