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Tag Archives: document management
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
Posted in PMCF & Registry Webinar, Uncategorized
Tagged cer for medical device, CERs, Clinical Data, Clinical Evidence Reports, Device product complaints, Device safety reporting, document management, Evaluation of clinical data, MDR, MDR Regulation, Medical Device, Medical Device Regulation, PMCF, PMCF & Registries, Registry
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Webinar on eTMF – Challenges, Opportunities & Trends
Essential Documents are the evidence that demonstrate Investigators, Sponsors, and Monitors have met the expectations of Good Clinical Practices (GCPs) and related regulations. The documentation stored in the Trial Master File is becoming increasingly digitized driving eTMF adoption across the … Continue reading
