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Podcast: Medical Device made Easy Podcast
Episode:

When is Regulatory Affairs needed during Design? 
Category: Business
Duration: 00:00:00
Publish Date: 2025-05-07 23:33:32
Description:
Miniature episode 335 Podcast: When is Regulatory Affairs needed during Design? Aouda Ouzza monir el azzouzi easy medical device

In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything and they need this person to take care of the registration before launch. But this is wrong, and we’ll let you know when and why you should involve them earlier. Listen to this episode. 

Who is Aouda Ouzzaa? 

Aouda Ouzzaa brings over 16 years of expertise in Regulatory Affairs (RA) and Quality Assurance (QA), supporting the entire product lifecycle—from development to post-market surveillance. She has successfully led projects across pharmaceuticals, biologics, medical devices (EU MDR), cosmetics, and Software as a Medical Device (SaMD). 

Her global regulatory knowledge spans EMA, FDA, GCC, and Rest of World (ROW) markets. Aouda has hands-on experience preparing IND, BLA submissions, and securing orphan drug designations. 

As a certified GMP and GDP auditor, Aouda has worked closely with cross-functional teams to ensure compliance with international standards while optimizing regulatory interactions. Her methodical approach and deep understanding of complex regulatory environments make her a strategic asset for organizations navigating global compliance challenges. 

Whether you’re developing a new drug, launching a medical device, or scaling a digital health solution, Aouda Ouzzaa brings the insight and precision needed to achieve regulatory success. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

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podcast episode 335 Podcast: When is Regulatory Affairs needed during Design? Aouda Ouzza monir el azzouzi easy medical device

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