Category Archives: Uncategorized

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 Matured/Established Products Regulatory Support & Models

Matured products go through multiple decisions in Global organization like: Keep or divest? Same teams or different teams to handle them? For regional support, who should pay? and more. All these stemming from cost pressures in global markets and changing … Continue reading

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Webinar on Next Generation of Central Monitor and Monitoring in RBM-Industry Updates

With the inclusion of centralized monitoring in risk based monitoring (RBM) approach; the Central Monitor is emerging as a key and important role in successful implementation of this new monitoring approach. The role of the Central Monitor and function of … Continue reading

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