Learn more about FDA QMSR alignment with ISO 13485

miniature episode 275 FDA aligns QMSR with ISO 13485? Naveen Agarwal the Creator of Let’s Talk Risk Monir El Azzouzi is the founder and CEO of Easy Medical Device

The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution? 

Naveen Agarwal from Exceed will answer this question. So don’t miss this episode to know more about QMSR. 

Who is Naveen Agarwal? 

Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.

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. 

Link: 

Social Media to follow

podcast episode 275 FDA aligns QMSR with ISO 13485? Naveen Agarwal the Creator of Let’s Talk Risk Monir El Azzouzi is the founder and CEO of Easy Medical Device

Available on:


Medical Device made Easy Podcast available on iTunes Apple - Powered by Easy Medical Device
Medical Device made Easy is available on Spotify - Powered by Easy Medical Device
Medical Device made Easy Podcast available on Stitcher Radio - powered by Easy Medical Device
Medical Device made Easy Podcast available on Tune In - Powered by Easy Medical Device
Medical Device made Easy Podcast is available on Podbean - Powered by Easy Medical Device
Alexa Skills Medical Device Podcast - Powered by Easy Medical Device