On this second part of the episode on OBL & OEM Model, Stefan Bolleininger from Be-On-Quality will focus now on the OEM side (Original Equipment Manufacturer).

We will try to answer the questions?

• What should do an OEM so his customers (OBL, PLM, Virtual Manufacturers) are capable to continue business with the new MDR 2017/745?

If you want to know more about the OBL side, you’ll need to go back to episode one https://podcast.easymedicaldevice.com/27

We will tell you how the OBL can be prepared for an audit to get CE certified.

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

■ Be on Quality website: https://be-on-quality.com

■ Linkedin: https://linkedin.com/in/melazzouzi

https://www.youtube.com/embed/qlyk8EEnwo0?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi