Webinar Overview

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.

Software used for the support of processes in quality management systems (QMS) must be validated to confirm that the software fulfills the intended purpose. Important to understand is, that the validation must be conducted on the basis of the application process and in the IT environment of the software operator.

Get a quick overview, which regulatory requirements are relevant for which products and easily integrate them into your product development process.

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.