In this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device.
Munir shares his expertise on the often confusing topic of the EU’s Medical Device Regulation (EUMDR), focusing on the distinctions between roles such as legal manufacturer, distributors, importers, authorized reps, and persons responsible for regulatory compliance.
Munir explains the need for compliance checks, supply chain management, traceability documentation, and regulatory responsibilities in the context of the EUMDR. He also discusses his company's role as an authorized representative, importer, and consultant, and the various services they offer to help medical device manufacturers navigate regulatory complexities.
00:03 Introduction and Guest Introduction
01:47 Understanding the Economic Operator Model
07:56 Legal Manufacturer
09:41 The Role of the Authorized Representative and PRRC
23:39 Understanding the Role and Responsibility of Authorized Representatives
26:14 The Role of Importers and Distributors
27:38 The Importance of Traceability in the Supply Chain
38:14 Terminating a Mandate with a Manufacturer
40:55 Conclusion and Easy Medical Device
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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses.
Easymedicaldevice.com
View all episodes
By Subhi Saadeh
4.9
1313 ratings
In this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device.
Munir shares his expertise on the often confusing topic of the EU’s Medical Device Regulation (EUMDR), focusing on the distinctions between roles such as legal manufacturer, distributors, importers, authorized reps, and persons responsible for regulatory compliance.
Munir explains the need for compliance checks, supply chain management, traceability documentation, and regulatory responsibilities in the context of the EUMDR. He also discusses his company's role as an authorized representative, importer, and consultant, and the various services they offer to help medical device manufacturers navigate regulatory complexities.
00:03 Introduction and Guest Introduction
01:47 Understanding the Economic Operator Model
07:56 Legal Manufacturer
09:41 The Role of the Authorized Representative and PRRC
23:39 Understanding the Role and Responsibility of Authorized Representatives
26:14 The Role of Importers and Distributors
27:38 The Importance of Traceability in the Supply Chain
38:14 Terminating a Mandate with a Manufacturer
40:55 Conclusion and Easy Medical Device
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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses.
Easymedicaldevice.com
8,646 Listeners
37,883 Listeners
30,688 Listeners
91 Listeners
110,822 Listeners
55,991 Listeners
9,510 Listeners
57,413 Listeners
15,488 Listeners