FDA aligns QMSR with ISO 13485?

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.
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►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.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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► Links from the Video
Naveen Agarwal Linkedin Profile: /
Learn more about Let's Talk Risk! here ans subscribe:
naveenagarwalphd.substack.com...
Webinar recording - Getting Ready for QMSR:
naveenagarwalphd.substack.com...
Risk management training on ACHIEVE:
www.achievexl.com/
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #regulatorycompliance

[@akashkirani5194]

Hello Monir and Naveen,
It was an amazing podcast and was able to understand why FDA aligned with 13485. I had one query, At a time interval from 13.00 minute to 13.10, Naveen says that Within 2 years manufacturers have to update their QMS to QMSR. I think it should be QSR to QMSR right. I would like to know if it is QMS or QSR to QMSR?? If I am wrong, can you please explain me in detail?
Thank You in advance

[@EasyMedicalDevice]

Hi, you are right from QSR to QMSR.