Easy Medical Device Podcast

Episode 28 – OBL & OEM Model (Part 2) with Stefan Bolleininger (Easy Medical Device)Podcast Episode 28 – OEM & OBL Model (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

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

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

How an OEM or Original Equipment Manufacturer can help the OBL (Own Brand Labeller) to continue business? Stefan Bolleininger from Be-On-Quality will help us on this second part of the Podcast. The post Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2 appeared first on Medical Device made Easy Podcast.

Episode 27 – OEM & 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 & 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.

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.com
• Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
• OBL/OEM Article: https://easymedicaldevice.com/own-brand-labelling/

https://www.youtube.com/embed/XiUHn7cZORw?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

The OEM and OBL model is under question with the new EU MDR and IVDR regulations. Stefan Bolleininger will help us understand how to continue to be compliant and continue business. The post Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1] appeared first on Medical Device made Easy Podcast.

Episode 26 – Prepare for IVDR with Andreas StangeEpisode 26 – IVDR preparation with Andreas Stange

We talked a lot about the EU MDR, but we should not forgot that there are also a similar change that is happening to the In-vitro Diagnostic Medical Devices with the EU IVDR 2017/746.

Manufacturers should be ready by May 26, 2022 but this will be really a huge work for them. Before only 20% of the products needed a notified body for placing their products on the market. Now with the IVDR it’S 80%.

So how should they prepare for that? Dr. Andreas Stange from TÜV SÜD will be my guest and answer questions about this new regulation. He will provide valuable information for the manufacturers to really focus on their journey to get certified.

Who is Dr. Andreas Stange?

Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD. Product Service. He serves as the global responsibility for the In-vitro Diagnostic Devices business line. Besides that, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia.

Dr. Stange joined TÜV SÜD in 2001 as a medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he served as President & CEO of TÜV SÜD in Japan for eight years.

Link

• Andreas Stange LinkedIn Profile: https://www.linkedin.com/in/andreasstange/
• TÜV SÜD notified body: https://www.tuvsud.com/
• IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746

https://www.youtube.com/embed/8WLGDp9zen4?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 26 – IVDR preparation with Andreas Stange appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Andreas Stange from TÜV SÜD will help us be prepared for the new IVDR or In-Vitro Diagnostic Regulation. This is a game changer for the manufacturers as more products are on the scope of a notified Body certification. The post Episode 26 – IVDR preparation with Andreas Stange appeared first on Medical Device made Easy Podcast.

Episode 25 – EUDAMED secrets with Richard HoulihanPodcast Episode 25 – Eudamed Secrets with Richard Houlihan

I know that you heard about something called EUDAMED but do you really know what it is? Do you really know what to do with it? and do you know how to prepare for it?

On this new episode of the Medical Device made Easy Podcast, I invited Richard Houlihan from EUDAMED.EU to discuss with us about the secret of EUDAMED.

What is interesting with Richard is that he was part of the project for the creation of this platform and how he created his own company to support manufacturers to be ready when EUDAMED will be launched.

On this episode we will answer few questions as:

• What is EUDAMED?
• When should we plan to use it?
• What is the situation at the European Commission?
• What companies should do to be prepared for it?
• What Eudamed.eu can do to help?

If you have not already planned a project for it, you should listen to this episode because this will help you to be ahead of competition.

Don’t forget to subscribe to this Podcast and if you like it please provide a review on your preferred platform.

Who is Richard Houlihan?

Richard Houlihan has been in IT-related businesses for 25+ years. He holds a BSc in Computing and an MBA Information management. The varying IT roles have led to him living in several countries, working across 6 blue chips, 3 start-ups and 3 different directorates within the European Commission.

Links

• Richard Houlihan LinkedIn: https://www.linkedin.com/in/richard-houlihan/
• Eudamed.eu Website: https://Eudamed.Eu
• Eudamed Cheat Sheet: https://podcast.easymedicaldevice.com/wp-content/uploads/2019/05/Eudamed_Cheat_sheet.pdf
• UDI article: https://easymedicaldevice.com/udi/
• Episode 4 – UDI: https://podcast.easymedicaldevice.com/4/

https://www.youtube.com/embed/XpfqPa6uFzo?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 25 – EUDAMED secrets with Richard Houlihan appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

EUDAMED is the new European Database for Medical Devices and this is something that can change completely the world of Medical Devices. For the consumers and the manufacturers. The post Episode 25 – EUDAMED secrets with Richard Houlihan appeared first on Medical Device made Easy Podcast.

Episode 24 – Myths about consultants with Thomas McMannAudio Episode 24 – Myths about consultants with Thomas McMann

On this episode, Thomas McMann from EPM Scientific who is in charge of the consultants and contractors recruitment in Switzerland will help us understand the difference between Full Time Employees (FTE), contractors and consultants.

He will also reveal to us the different myths that exist and we’ll discuss the reason people think about them. And you, for your Medical Device Regulation projects, have you hired a permanent employee, a contractor or a consultant. Please let me know on the comments and also the reason for that.

What is EPM SCientific

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. As an industry expert, we understand that the ongoing changes within the Pharmaceutical industry make the ability to attract and maintain industry-leading talent a key priority.

Links

• Thomas McMann Linkedin: https://www.linkedin.com/in/thomas-mcmann-05540a10b/
• EPM Scientific website: www.epmscientific.com
• EPM Scientific Linkedin: https://www.linkedin.com/company/epm-scientific/
• EPM Scientific Twitter: https://www.twitter.com/EPMScientific
• EPM Scientific Instagram: https://www.instagram.com/phaidoncareers/
• Episode Petra Ognjenovic: https://podcast.easymedicaldevice.com/18

https://www.youtube.com/embed/hQD9zdI1ZxY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 24 – Myths about consultants with Thomas McMann appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Are you hiring contractors or consultants for your projects? Do you know the difference or do you know what are the myths about them? Thomas McMann from EPM Scientific is sharing that with us. The post Episode 24 – Myths about consultants with Thomas McMann appeared first on Medical Device made Easy Podcast.