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.
Timestamps
- 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
