Nicolaj Nitzsch's guest appearances

Nicolaj Nitzsch

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

The new Medical Device Regulation EU MDR 2017/745 and IVDR 2017/746 is providing some new vocabulary like “Economic Operators” and we will focus on one of them on this episode which is the Distributor.The distributor has a particular responsibility within the new regulation. And this also means that some Distributors should update their Quality System or update some agreements they have with manufacturers.Nicolaj Nitzsch is a Sales Manager at Scan-Med Norway and he is providing some support to understand what distributors should do to upgrade their system. In this discussion, you will see that a lot of things were already in place for distributors before the new Medical Device Regulation, but with the MDR and IVDR, this should now be properly documented.On the links below, I also included an article about another economic operator which is the European Authorized Representative.Who is Nicolaj Nitzsch  With over 7 years of experience in the medical device filed where I over the years have developed a strong understanding of the importance of devices and the industry.I have an education as a Data Technician Specializing in Infrastructure and have a strong mindset for business optimizing in the Nordic market.I’m passionate about technology in general, Business Development and the industry of Medical and Health Tech because this is something that really can change the quality of life for patients.LinksNicolaj Nitzsch LinkedIn:  https://www.linkedin.com/in/nitzsch/ ScanMed Norway:  https://scan-med.com/ Distributor Roles and Responsibility: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745#d1e2774-1-1Easy Medical Device Shop: https://school.easymedicaldevice.com/shopEconomic Operator: European Authorized Representative: https://easymedicaldevice.com/ec-authorized-representative/The post Responsibility of a Distributor in MDR &amp; IVDR with Nicolaj Nitzsch first appeared on Medical Device made Easy Podcast.The post Responsibility of a Distributor in MDR &amp; IVDR with Nicolaj Nitzsch appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

<p>The new Medical Device Regulation EU MDR 2017/745 and IVDR 2017/746 is providing some new vocabulary like “Economic Operators” and we will focus on one of them on this episode which is the Distributor.</p><p>The distributor has a particular responsibility within the new regulation. And this also means that some Distributors should update their Quality System or update some agreements they have with manufacturers.</p><p>Nicolaj Nitzsch is a Sales Manager at Scan-Med Norway and he is providing some support to understand what distributors should do to upgrade their system. </p><p>In this discussion, you will see that a lot of things were already in place for distributors before the new Medical Device Regulation, but with the MDR and IVDR, this should now be properly documented.</p><p>On the links below, I also included an article about another economic operator which is the European Authorized Representative.</p><h2>Who is Nicolaj Nitzsch</h2><p>  With over 7 years of experience in the medical device filed where I over the years have developed a strong understanding of the importance of devices and the industry.</p><p>I have an education as a Data Technician Specializing in Infrastructure and have a strong mindset for business optimizing in the Nordic market.<br/>I’m passionate about technology in general, Business Development and the industry of Medical and Health Tech because this is something that really can change the quality of life for patients.</p><h2>Links</h2><ul><li>Nicolaj Nitzsch LinkedIn:  <a href="https://www.linkedin.com/in/nitzsch/" rel="noreferrer noopener nofollow" target="_blank">https://www.linkedin.com/in/nitzsch/</a> </li><li>ScanMed Norway:  <a href="https://scan-med.com/" rel="noreferrer noopener nofollow" target="_blank">https://scan-med.com/</a> </li><li>Distributor Roles and Responsibility: <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745#d1e2774-1-1" rel="noreferrer noopener nofollow" target="_blank">https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745#d1e2774-1-1</a></li><li>Easy Medical Device Shop: <a href="https://school.easymedicaldevice.com/shop" rel="noreferrer noopener nofollow" target="_blank">https://school.easymedicaldevice.com/shop</a></li><li>Economic Operator: European Authorized Representative: <a href="https://easymedicaldevice.com/ec-authorized-representative/" rel="noreferrer noopener nofollow" target="_blank">https://easymedicaldevice.com/ec-authorized-representative/</a></li></ul><p>The post <a href="https://podcast.easymedicaldevice.com/51/" rel="nofollow" target="_blank">Responsibility of a Distributor in MDR &amp; IVDR with Nicolaj Nitzsch</a> first appeared on <a href="https://podcast.easymedicaldevice.com" rel="nofollow" target="_blank">Medical Device made Easy Podcast</a>.</p><p>The post <a href="https://podcast.easymedicaldevice.com/51/" rel="nofollow" target="_blank">Responsibility of a Distributor in MDR &amp; IVDR with Nicolaj Nitzsch</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></p>

Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch