Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1]
OEM and OBL – It’s been a few months that this question was asked to me and the interpretation of the MDR 2017/745 or IVDR 2017/746 was not really easy.
This is why I tried to find someone to help us to define if OBL/PLM/Virtual Manufacturer & OEM Model is still existing with the new Medical Device Regulation.
- OBL: Own Brand Labeler
- PLM: Private Labeling Manufacturer
- OEM: Original Equipment Manufacturer
Stefan Bolleininger from Be-on-quality.com accepted to participate in the Medical Device made Easy Podcast and answer my questions.
He will define with us what is the best strategy to continue business and we will first start with the OBL/PLM/Virtual Manufacturer and on the second part, we will focus on the OEM.
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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”.
- 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/