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. 

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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

One Reply to “Learn more about FDA QMSR alignment with ISO 13485”

  1. Richard J Sainz

    Hello Easy Medical Device Representative….
    I am a Quality Assurance Manager with a medical device company in CT. USA.
    As we continue to grow our organization, we are finding how best to align our QMS with ISO 13485:2016 and QSR/QSMR.
    The challenges is aligning our current QMS with that of EU_MDR 2017/745.
    We have found documentation where ISO and QSR are compared, and how ISO clauses align with which QSR regulation.

    My question….
    Is here such a document that compares EU_MDR 2017/745 with either ISO13485:2016 or the FDA QSR?
    We already have a matrix that compares ISO and FDA, but having a difficult time locating one that compares either of these to EU_MDR 2017/745.

    Greatly appreciate the assistance…
    Richard

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