Manufacturers are responsible for ensuring medical devices meet all applicable requirements of the (EU) 2017/745 Medical Devices Regulation (MDR) prior to them being placed on the European market. Technical documentation(s) is required for all classes of devices and all but class I technical documentation must be evaluated by a Notified Body.
Learn in this on-demand webinar ways to minimize the pain of getting your technical documentation through the review performed by the Notified Body.
Learning Objectives
- Learn about pitfalls when submitting your technical documentation for approval and suggestions on how to avoid them
- Common areas of questions from Notified Bodies regarding your technical documentation and examples of the tools we will use to minimize the chance of questions from the Notified Body
- How our services can support your technical documentation and QMS submissions.
Watch the webinar on-demand below, or download the presentation.