Рет қаралды 208
This Medical Device Live Expert Session Number 2 provided a lot of information viewed from our US experts. Monir El Azzouzi interviewed Michelle Lotte, Rob Packard and Harsh Thakkar and reviewed with them 3 topics:
- MDR viewed by the US manufacturers and Consultants
- QMSR, is this changing something for US manufacturers
- Is AI easier in the US now that they issued multiple guidance.
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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
Michelle Lott Linkedin Profile: / michellelottraqa
Rob Packard Linkedin Profile: / deviceqms
Harsh Thakkar Linkedin Profile: / harshvthakkar
QMSR FDA link: www.fda.gov/me...
AI FDA guidelines: www.fda.gov/me...
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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