Webinar Overview
Look forward to exciting topics, lots of input and inspirations for more efficient work.
In this webinar, we will introduce you to the new features in avaClinical 2.0 and their benefits.
In this webinar find out more on how avasis and their Polarion products can help you implementing state-of-the-art digitalized processes in the medtech industry.
This on-demand webinar highlights efficient regulatory information management, integrating data into Polarion with avaREGULATORY, and guiding your company to prepare for upcoming changes through SMART standards.
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.
This Tech-Talk explores the interface between risk management and clinical evaluation in medical devices. It covers topics like data exchange, traceability, and consistency between plans and reports, while addressing challenges in post-market surveillance and unresolved industry issues.
When a process is digitized with the help of a software, validation of the software is mandatory. This is required by ISO 13485 and also by the FDA in 21 CFR Part 820. However, there are significant differences in the concrete approach and the required effort.Therefore, it is crucial to have an appropriate software validation process established that allows flexibility for the different use scenarios.
It's no secret: One of the biggest challenges in product development are "silos" of information. They arise from processes that are not interlinked and specialist process teams that are not able to exchange information efficiently
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.