Stefan Bolleininger's guest appearances

Stefan Bolleininger

Medical Device made Easy Podcast

Jason Lim

Erik Vollebregt

Tania Aprigliano

Michelle Lott

Ed Drower

Justin Bushko

Natasha Bankowski

Helene Quie

Mitch Robbins

Sharon Ayd

Karandeep Badwal

Samantha Alsbury

Sean Hamilton

Angelina Hakim

Richard Young

OwlTail

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”. LinksStefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/Be-on-quality: https://be-on-quality.com5 Steps to create a Quality Management System: https://easymedicaldevice.com/5-steps-quality-management-system/ISO 13485 standard: https://bit.ly/368Xvl0Frequently asked questions on ISO 13485: https://easymedicaldevice.com/faq-iso-13485/ The post How to create a QMS compliant to MDR with Stefan Bolleininger first appeared on Medical Device made Easy Podcast.The post How to create a QMS compliant to MDR with Stefan Bolleininger appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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: <ul><li>Should you apply to ISO 13485? </li><li>Is it mandatory? </li><li>Do you need to contact a Notified Body or are there other options? </li></ul>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. <h2> Who is Stefan Bolleininger ?</h2>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”. <h2>Links</h2><ul><li>Stefan Bolleininger LinkedIn: <a href="https://www.linkedin.com/in/stefan-bolleininger-3a717028/" rel="noreferrer noopener nofollow" target="_blank">https://www.linkedin.com/in/stefan-bolleininger-3a717028/</a></li><li>Be-on-quality: <a href="https://be-on-quality.com" rel="noreferrer noopener nofollow" target="_blank">https://be-on-quality.com</a></li><li>5 Steps to create a Quality Management System: <a href="https://easymedicaldevice.com/5-steps-quality-management-system/" rel="noreferrer noopener nofollow" target="_blank">https://easymedicaldevice.com/5-steps-quality-management-system/</a></li><li>ISO 13485 standard: <a href="https://bit.ly/368Xvl0" rel="noreferrer noopener nofollow" target="_blank">https://bit.ly/368Xvl0</a></li><li>Frequently asked questions on ISO 13485: <a href="https://easymedicaldevice.com/faq-iso-13485/" rel="noreferrer noopener nofollow" target="_blank">https://easymedicaldevice.com/faq-iso-13485/ </a></li></ul>The post <a href="https://podcast.easymedicaldevice.com/59/" rel="nofollow" target="_blank">How to create a QMS compliant to MDR with Stefan Bolleininger</a> first appeared on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>.The post <a href="https://podcast.easymedicaldevice.com/59/" rel="nofollow" target="_blank">How to create a QMS compliant to MDR with Stefan Bolleininger</a> appeared first on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>. <a href="https://podcast.easymedicaldevice.com/author/melazzouzi/" rel="nofollow" target="_blank">Monir El Azzouzi</a>

How to create a QMS compliant to MDR with Stefan Bolleininger

Episode 28 – OBL &amp;  OEM Model (Part 2) with Stefan Bolleininger (Easy Medical Device)    Podcast Episode 28 – OEM &amp; OBL Model (Part 2)     On this second part of the episode on OBL &amp; 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 &amp; 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 The post Episode 28 – OBL &amp; OEM with Stefan Bolleininger – Part 2 first appeared on Medical Device made Easy Podcast.The post Episode 28 – OBL &amp; OEM with Stefan Bolleininger – Part 2 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 28 – OBL &amp; OEM Model (Part 2) with Stefan Bolleininger (Easy Medical Device) Podcast Episode 28 – OEM &amp; OBL Model (Part 2) On this second part of the episode on OBL &amp; 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? <ul><li>What should do an OEM so his customers (OBL, PLM, Virtual Manufacturers) are capable to continue business with the new MDR 2017/745?</li><li>How they should prepare for a Notified Body Audit?</li><li>What are the documents they should supply without delivering all there secrets?</li></ul> If you want to know more about the OBL side, you’ll need to go back to episode one <a href="https://podcast.easymedicaldevice.com/27" rel="nofollow" target="_blank">https://podcast.easymedicaldevice.com/27</a> We will tell you how the OBL can be prepared for an audit to get CE certified. <h2>Who is Stefan Bolleininger</h2> 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”. <h2>Links from the Video</h2> ■ Be on Quality website: <a href="https://be-on-quality.com" rel="noreferrer noopener nofollow" target="_blank">https://be-on-quality.com</a> ■ Stefan Bolleininger LinkedIn: <a href="https://www.linkedin.com/in/stefan-bolleininger-3a717028/" rel="noreferrer noopener nofollow" target="_blank">https://www.linkedin.com/in/stefan-bolleininger-3a717028/</a> ■ OBL/OEM Article: <a href="https://easymedicaldevice.com/own-brand-labelling/" rel="noreferrer noopener nofollow" target="_blank">https://easymedicaldevice.com/own-brand-labelling/</a> ■ Episode 27 – OBL &amp; OEM Part 1: <a href="https://podcast.easymedicaldevice.com/27" rel="noreferrer noopener nofollow" target="_blank">https://podcast.easymedicaldevice.com/27</a> <h2>Social Media to follow</h2> ■ Linkedin: <a href="https://linkedin.com/in/melazzouzi" rel="nofollow" target="_blank">https://linkedin.com/in/melazzouzi</a> ■ Twitter: <a href="https://twitter.com/elazzouzim" rel="nofollow" target="_blank">https://twitter.com/elazzouzim</a> ■ Pinterest: <a href="https://www.pinterest.com/easymedicaldevice" rel="nofollow" target="_blank">https://www.pinterest.com/easymedicaldevice</a> ■ Instagram: <a href="https://www.instagram.com/easymedicaldevice" rel="nofollow" target="_blank">https://www.instagram.com/easymedicaldevice</a> The post <a href="https://podcast.easymedicaldevice.com/28/" rel="nofollow" target="_blank">Episode 28 – OBL &amp; OEM with Stefan Bolleininger – Part 2</a> first appeared on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>.The post <a href="https://podcast.easymedicaldevice.com/28/" rel="nofollow" target="_blank">Episode 28 – OBL &amp; OEM with Stefan Bolleininger – Part 2</a> appeared first on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>. <a href="https://podcast.easymedicaldevice.com/author/melazzouzi/" rel="nofollow" target="_blank">Monir El Azzouzi</a>

Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2

Episode 27 – OEM &amp; OBL Model with Stefan BolleiningerPodcast Episode 27 – OEM and 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 &amp; OEM Model is still existing with the new Medical Device Regulation. OBL: Own Brand LabelerPLM: Private Labeling ManufacturerOEM: 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. Don’t forget to subscribe and provide a review to the Podcast if you like what I am doing on it. This will really help me. Thanks for your support. 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 Be on Quality website: https://be-on-quality.comStefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/OBL/OEM Article: https://easymedicaldevice.com/own-brand-labelling/ The post Episode 27 – OEM &amp; OBL Model with Stefan Bolleininger [Part 1] first appeared on Medical Device made Easy Podcast.The post Episode 27 – OEM &amp; OBL Model with Stefan Bolleininger [Part 1] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Episode 27 – OEM &amp; OBL Model with Stefan Bolleininger Podcast Episode 27 – OEM and 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 &amp; OEM Model is still existing with the new Medical Device Regulation. <ul><li>OBL: Own Brand Labeler</li><li>PLM: Private Labeling Manufacturer</li><li>OEM: Original Equipment Manufacturer</li></ul> Stefan Bolleininger from <a href="https://Be-on-quality.com" rel="noreferrer noopener nofollow" target="_blank">Be-on-quality.com</a> 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. Don’t forget to subscribe and provide a review to the Podcast if you like what I am doing on it. This will really help me. Thanks for your support. <h2>Who is Stefan Bolleininger?</h2> 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”. <h2>Links</h2> <ul><li>Be on Quality website: <a href="https://be-on-quality.com" rel="noreferrer noopener nofollow" target="_blank">https://be-on-quality.com</a></li><li>Stefan Bolleininger LinkedIn: <a href="https://www.linkedin.com/in/stefan-bolleininger-3a717028/" rel="noreferrer noopener nofollow" target="_blank">https://www.linkedin.com/in/stefan-bolleininger-3a717028/</a></li><li>OBL/OEM Article: <a href="https://easymedicaldevice.com/own-brand-labelling/" rel="noreferrer noopener nofollow" target="_blank">https://easymedicaldevice.com/own-brand-labelling/</a></li></ul> The post <a href="https://podcast.easymedicaldevice.com/27/" rel="nofollow" target="_blank">Episode 27 – OEM &amp; OBL Model with Stefan Bolleininger [Part 1]</a> first appeared on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>.The post <a href="https://podcast.easymedicaldevice.com/27/" rel="nofollow" target="_blank">Episode 27 – OEM &amp; OBL Model with Stefan Bolleininger [Part 1]</a> appeared first on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>. <a href="https://podcast.easymedicaldevice.com/author/melazzouzi/" rel="nofollow" target="_blank">Monir El Azzouzi</a>