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Why Risk Management is critical to Medical Device Development?
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Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, FDA QSR, MDSAP... All of them talk about Risk Management. You should manage your risks. But why is this so important or even critical? This is what we will discuss with Kailash Kalidoss who is a Medical Device Engineer and also a NASA Ambassador. He will share with us his experience.
PS: if your company needs an EU, UK or Swiss Authorized representative or Importer, don't hesitate to contact Easy Medical Device. See the link below.
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► Who is Kailash Kalidoss?
The foundation of my professional experience is in consulting for complex MedTech projects, from conceptualization to product release. In my 13+ years of experience, I have worked as a Design control consultant for various leading US-based Medical Device Companies. I’m also certified by AAMI for Medical Quality System Regulations. Currently, I work for a cutting-edge engineering consulting firm based out of the Bay area in California.
Academically my career is well rounded with an MBA from a prestigious B-School. Also, I have good exposure to STEM fields through MS and Engineering Bachelor degrees earlier, to effectively complement the B-School erudition.
SPECIALITIES: Medical Device Design Control, Verification, and Validation, Software in Medical Devices and SaMD, Quality, Medical Device Regulations
BEYOND WORK: Aerospace Educator for Civil Air Patrol, a United States Airforce Auxiliary. NASA Solar System Ambassador.
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► Who is Monir El Azzouzi?
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► Links from the Video
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► Social Media to follow
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#easymedicaldevice #medicaldevice #regulatorycompliance
PS: if your company needs an EU, UK or Swiss Authorized representative or Importer, don't hesitate to contact Easy Medical Device. See the link below.
------------------------------------------------------------------------------------------------
► Who is Kailash Kalidoss?
The foundation of my professional experience is in consulting for complex MedTech projects, from conceptualization to product release. In my 13+ years of experience, I have worked as a Design control consultant for various leading US-based Medical Device Companies. I’m also certified by AAMI for Medical Quality System Regulations. Currently, I work for a cutting-edge engineering consulting firm based out of the Bay area in California.
Academically my career is well rounded with an MBA from a prestigious B-School. Also, I have good exposure to STEM fields through MS and Engineering Bachelor degrees earlier, to effectively complement the B-School erudition.
SPECIALITIES: Medical Device Design Control, Verification, and Validation, Software in Medical Devices and SaMD, Quality, Medical Device Regulations
BEYOND WORK: Aerospace Educator for Civil Air Patrol, a United States Airforce Auxiliary. NASA Solar System Ambassador.
-------------------------------------------------------------------------------------------------
► Who is Monir El Azzouzi?
--------------------------------------------------------------------------------------------
► Links from the Video
-------------------------------------------------------------------------------------------
► Social Media to follow
------------------------------------------------------------------------------------------
#easymedicaldevice #medicaldevice #regulatorycompliance
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