Tag Archives: Evaluation of clinical data

Webinar on Importance & Requirements of Clinical Evaluation for CER

The revised guidance MEDDEV 2.7/1 rev 4 reveals a course of changes to a more prescriptive and demanding set of expectations. A sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate … Continue reading

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Webinar on Growing need of Clinical Data, PMCF & Registries for Devices

  Post Market Clinical Follow Up (PMCF) studies are a critical component of the clinical evidence required to comply with the new European regulations. As Clinical Evidence Reports (CERs) encounter more and more scrutiny by Notified Bodies (NBs), the gaps … Continue reading

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