Module 19 2021

Intended Purpose and Clinical Performance

Art. 2.41. ‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user;

Scientific Validity

Commercial Implications

Clinical Performance

About all elements of the Intended Purpose will have an impact on the Clinical Performance to established.

Intended Purpose

… and on the Clinical Performance Studies

Risk Management

Classification

Liability

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