The EU MDR 2017/745 was extended but does this change something for you? Do you need to apply to your notified body later? What can be the promise made by your Notified Body? Can they advice you? Pritam from TÜV SÜD will be answering my question without any taboo. So don't hesitate also to go to the show notes and see his details as at the end of the video he will be making you a promise. So don't miss this opportunity.

And if you need some support for your Notified Body application contact us at Easy Medical Device.

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, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. 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 also acts 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.

Who is Pritam Mekala? 

Pritam Mekala is an enthusiastic, ambitious, and motivated medical device expert. Born in India, grew up in America, studied in the US, and currently living and working in Toronto, Canada, Pritam is an ensemble of multi-national, multi-cultural and multi-linguistic personality. He currently works at TÜV SÜD, as a Product Expert & Auditor in their Medical Health Sciences (MHS) Product Assessment Team (PAT). 

Before joining the Notified Body team, Pritam worked as a was project engineer at Abbott on their infamous BinaxNOW - COVID Test Kit project. He also worked at other notable medical device manufacturers such as Medtronic, Covidien, Zimmer Biomet etc.  

On the education front, Pritam graduated from the Oklahoma State University with a master’s in mechanical and aerospace engineering with research & specialization in Biomedical Engineering. 

As a representative of Notified Body, TÜV SÜD, Pritam can help you facilitate: 

Free 30minute Call (at no additional cost) *NOT CONSULTATION* 

Free Budgetary quote (for review & comparison) 

Free Technical Documentation Guidance (at no additional cost) 

Links from the Video

Profile LinkedIn:  https://www.linkedin.com/in/pritam-mekala/

Email: [email protected] 

Company website: https://www.tuvsud.com/en-us 

Relevant MDCG Announcements: 

https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf 

https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf 

https://health.ec.europa.eu/latest-updates/mdcg-2022-14-transition-mdr-and-ivdr-notified-body-capacity-and-availability-medical-devices-and-2022-08-26_en 

TÜV SÜD Structure Dialogue:  

https://ts.tuvsud.com/rs/819-PVY-502/images/T%C3%9CV%20S%C3%9CD%20Structured%20Dialogue%20-%20customer%20presentation.pdf?version=0&mkt_tok=ODE5LVBWWS01MDIAAAGO-2Fg5uIG2idWOUuPQkEspBBKLOHU1vf9rLoMqzR2t_pnXJguMMpidTQA5rQbAJ-uIcPpYp3S4QS8SV6R1wE2GeN8IJNMyV2HJf24YyQdGxo

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice