Read or download the eBook by clicking on the image above (or here).
With organizations now 4 months in following the EU MDR entering into application on 26 May 2021, there are a number of questions facing the industry around implementation, QA and RA, legacy products, and ‘sufficient clinical evidence’. In this MedTech Series eBook we explore these issues.
What are the biggest challenges facing organizations, both internally with optimizing processes and externally with issues out of their control? How many products have been registered under MDR and how many extended under the MDD? In August, we conducted a global research study of medical device professionals around the world to understand how organizations have fared with EU MDR implementation and the biggest obstacles that still remain. Here we offer a sneak peek of some of the initial insights before the launch of the full report later this month.
Demonstrating "sufficient clinical evidence" is another aspect of EU MDR the industry is currently grappling with. We attempt to answer what exactly is meant by "sufficient clinical evidence", the data sources that can be used and how legacy products fit into it.
And finally, Veeva looks at how to solve a common communication breakdown in medtech, offering solutions for getting QA and RA on the same page for more efficient medtech manufacturing.
Read or download the eBook by clicking on the image above (or here).