How to select your Notified Body and understand the full process?

I know you are struggling with that so I will explain to you what we learned applying to multiple Notified Bodies. This is difficult and you should really plan the process ahead and not wait the last minute.

The post How to select your Notified Body and understand the full process? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

The selection of Notified Bodies in Europe can be a real challenge and I will explain to you in this Podcast episode how to do it so you can understand the process and get the real outcome for your projects.

There are 33 Notified Bodies for EU MDR 2017/745 at the time of this podcast. This is lower than the number of Notified Bodies that were under EU MDD 93/42/EC so this means that there will be a big bottleneck. So let us help you go over it and really make the right decisions.

To get all the information about this process with Notified Bodies, go to the Annex VII of the EU MDR and IVDR

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company is also acting as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

NANDO Database: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 First audits conclusion episode with Martin Witte: https://podcast.easymedicaldevice.com/140/ Qualitiso Notified Body price: https://www.qualitiso.com/en/comparison-of-notified-body-fees/ EU MDR link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128#tocId166 Technical File Episode: https://podcast.easymedicaldevice.com/191/ Expert Panel Episode with Bassil Akra: https://podcast.easymedicaldevice.com/102/ First results of Expert Panel Episode with Bassil Akra: https://podcast.easymedicaldevice.com/136/ TÜV SÜD pre-application form: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-request-for-service-registration

The post How to select your Notified Body and understand the full process? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi