Author Archives: makrocarewebinars

Webinar on Risk Management EU MDR Perspective

Risk management is understood as a continuous iterative process throughout the entire life cycle of a device, requiring regular systematic updating. Though Risk management has been a requirement in MDD also, EU MDR places greater emphasize on this area. EU … Continue reading

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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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Webinar on Explore rSDV for Clin Ops efficiency & Cost Saving

          While on-site monitoring is one of the biggest cost drivers of clinical trial operations, Remote Source Document Verification (rSDV) offers the best alternative to significantly reduce onsite monitoring activities to build efficiencies, data quality and … Continue reading

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