Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2
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?
- How they should prepare for a Notified Body Audit?
- What are the documents they should supply without delivering all there secrets?
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.
Who is Stefan Bolleininger
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”.
Links from the Video
■ Be on Quality website: https://be-on-quality.com
■ Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
■ OBL/OEM Article: https://easymedicaldevice.com/own-brand-labelling/
■ Episode 27 – OBL & OEM Part 1: https://podcast.easymedicaldevice.com/27
Social Media to follow
■ Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice