Webinar Overview

Discover how to overcome complex challenges in medical technology with Teamcenter Medical Device Solution. Optimize team collaboration, streamline project management, and enhance product development. Join our webinar to learn proven strategies for efficiency and success. 

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. 

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.

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