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Clinical Evaluation
Computer System Validation (CSV/CSA)
Digitalization Trends
Post-market Clinical Follow-up (PMCF)
Post-market Surveillance (PMS)
Product Development
Regulatory Information
Risk Management
Technical Documentation
Usability Engineering
Post-Market Surveillance – Adverse Event Database Search
In this webinar, we will present you our new Polarion solution avaADVERSE, which was developed for a digitalized procedure for searches in adverse event databases and an automated interface to the FDA databases MAUDE and Recall.
Post-Market Surveillance
Post-market Surveillance (PMS) is one of the most complex processes in medical device quality management systems due to its interface to many other processes. Get more Information in this TechTalk.
IMDRF Adverse Event Coding
Dieses Webinar gibt einen Überblick über die Coding Struktur und verwendete Kategorien von Terminologien. Darauf basierend wird erläutert, wie das Coding für verschiedene Prozesse des Qualitätsmanagementsystems angewendet wird.