This webinar will address the requirements for software medical devices under the Medical Device Regulation (EU 2017/745) and propose strategies to ensure compliance.
This webinar will address the proposed to changes required for your technical file under the Medical Device Regulation (EU 2017/745).
This webinar will address the new requirements for clinical data under the Medical Device Regulation (EU 2017/745) and propose practical strategies to ensure a smooth transition for manufacturers of devices currently CE marked under the Medical Device Directive (93/42/EEC).
A new version of the European Guideline MEDDEV 2.7/1 rev 4 was issued in June 2016 affecting all companies that market medical devices in Europe.
The MEDDEV is a guidance document and therefore there is no implementation period. Therefore, it is important to start using the new version. The general principle in performing a clinical evaluation report remains the same. The manufacturer must use clinical data to demonstrate compliance with relevant Essential Requirements. Such data still has to be based on investigations done with the subject device and data from post-market surveillance (PMS) activities and vigilance activities where appropriate.
This webinar will cover how FDA’s regulations, processes and recommendations for clinical studies of medical devices in the US (whether they are for 510(k)s or PMAs), including significant and nonsignificant risk studies, early feasibility, feasibility and pivotal studies, use of clinical data from outside the US, and pre-submissions. There will also be ample time for questions after the presentation.