Webinarübersicht

In this webinar we will introduce you to the new features in avaClinical 2.0 and their benefits.

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. 

A huge problem in the MedTech industry: The 𝗶𝗻𝘁𝗲𝗿𝗳𝗮𝗰𝗲 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 & 𝗿𝗶𝘀𝗸 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗳𝗶𝗹𝗲, and in particular the 𝗯𝗲𝗻𝗲𝗳𝗶𝘁-𝗿𝗶𝘀𝗸 𝗱𝗲𝘁𝗲𝗿𝗺𝗶𝗻𝗮𝘁𝗶𝗼𝗻 section in the clinical evaluation report. We strive to bring more clarity into that topic and help you understand current struggles of medical device manufacturers and how you can handle those.

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.

Regulatory requirements for clinical evaluations of medical devices increased over the last years. An important tool to reduce time and labor are software solutions for digital documentation.

In this on-demand webinar we will explain the interfaces and demonstrate, how you can link information between these processes in Polarion in order to demonstrate compliance with regulatory requirements.

Unsere digitale Polarion Lösungt hilft Ihnen, effizient eine vollständige und konsistente klinische Bewertung zu schreiben und verhindert damit formelle Auditabweichungen und Verzögerungen bei der Zulassung.