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Glossary

Clinical Evaluation Report (CER)

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Required under the new MEDDEV 2.7.1 Rev. 3 guidelines.

Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device.

Other glossary definitions

U

UDI – Unique Device Identifier

A series of numeric or alphanumeric characters that is created through internationally accepted device identification…

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H

Health Economics and Outcomes Research (HEOR)

Health Economics and Outcomes Research (HEOR) is the most common label given to the function within pharmaceutical…

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