How to create a QMS compliant to MDR with Stefan Bolleininger
In this episode of the Medical Device made Easy Podcast, Monir El Azzouzi, and Stefan Bolleininger are helping you to create your quality management system with the objective to be compliant to EU MDR 2017/745 or EU IVDR 2017/746 Now even class I devices should have a Quality Management System, but:
- Should you apply to ISO 13485?
- Is it mandatory?
- Do you need to contact a Notified Body or are there other options?
We will help you by providing a step by step understanding on how to get a Quality Management System. We will also help you understand the audit process.
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 Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.
Links
- Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
- Be-on-quality: https://be-on-quality.com
- 5 Steps to create a Quality Management System: https://easymedicaldevice.com/5-steps-quality-management-system/
- ISO 13485 standard: https://bit.ly/368Xvl0
- Frequently asked questions on ISO 13485: https://easymedicaldevice.com/faq-iso-13485/
