Asaf Azulay
Managing Director Eurofins Li-Med Israel at Eurofins | Li-Med RA & QA Experts- Claim this Profile
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Hebrew Native or bilingual proficiency
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English Native or bilingual proficiency
Topline Score
Bio
Rami Boochnick
Asaf conducted our firm a mock audit in preparation to FDA combination product audit (CFR 820). Asaf audit was conducted in very professional respecting and educating manner. Asaf provided a lot of good tips, that allowed us to better prepare to the FDA audit. The FDA audit felt almost identical to the mock audit Asaf has conducted, and when you are well prepared you succeed. The audit was completed with no 483 observation. I highly recommend Assaf
Rami Boochnick
Asaf conducted our firm a mock audit in preparation to FDA combination product audit (CFR 820). Asaf audit was conducted in very professional respecting and educating manner. Asaf provided a lot of good tips, that allowed us to better prepare to the FDA audit. The FDA audit felt almost identical to the mock audit Asaf has conducted, and when you are well prepared you succeed. The audit was completed with no 483 observation. I highly recommend Assaf
Rami Boochnick
Asaf conducted our firm a mock audit in preparation to FDA combination product audit (CFR 820). Asaf audit was conducted in very professional respecting and educating manner. Asaf provided a lot of good tips, that allowed us to better prepare to the FDA audit. The FDA audit felt almost identical to the mock audit Asaf has conducted, and when you are well prepared you succeed. The audit was completed with no 483 observation. I highly recommend Assaf
Rami Boochnick
Asaf conducted our firm a mock audit in preparation to FDA combination product audit (CFR 820). Asaf audit was conducted in very professional respecting and educating manner. Asaf provided a lot of good tips, that allowed us to better prepare to the FDA audit. The FDA audit felt almost identical to the mock audit Asaf has conducted, and when you are well prepared you succeed. The audit was completed with no 483 observation. I highly recommend Assaf
Credentials
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MDR Master class
MeditrialJan, 2020- Nov, 2024 -
Extractble and Leachables
EurofinsJan, 2019- Nov, 2024 -
Biological evaluation for medical device
NAMSAJan, 2017- Nov, 2024 -
Heart Valves
TÜV SÜDJan, 2017- Nov, 2024 -
ICQE, Certified Quality Engineer
ISQ - Israel Society for QualityJan, 2003- Nov, 2024
Experience
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Eurofins | Li-Med
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Israel
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Medical and Diagnostic Laboratories
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1 - 100 Employee
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Managing Director Eurofins Li-Med Israel
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Apr 2022 - Present
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Founder and CEO Li-Med
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Dec 2007 - May 2022
Li-Med provides domestic and international regulation administration as well as quality assurance services. By implementing our expertise and understanding of QA & RA system requirements, Li-Med has been successful in assisting medical companies pass the FDA, CE, and other application processes. We specialize in QA & RA services to:• Medical devices• Cardiovascular devices• Pharma and combination products• Software as medical device• Electrical Devices• Neurological devices• IVD• Active devicesMy expertise include the following:• Perform Regulatory and Quality due diligences as part of M&A process• leading FDA, CE Regulatory strategy• Lead and support regulatory submissions US FDA and CE• Performing internal and subcontractors audits• Managing Risk and Design Control activities• Implementation of QMS Show less
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Transseptal solutions
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Israel
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Medical Device
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1 - 100 Employee
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Director QA & RA
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Nov 2013 - May 2022
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Bendit Technologies
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Israel
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Medical Device
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1 - 100 Employee
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Co Founder and VP QA RA
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Jun 2013 - Jul 2019
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Valtech Cardio
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Israel
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Medical Equipment Manufacturing
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1 - 100 Employee
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VP QA & RA
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Dec 2011 - Dec 2014
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QA/RA Director
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Oct 2008 - Dec 2011
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QA Manager
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Oct 2004 - May 2008
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Neurosonix
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Medical Equipment Manufacturing
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1 - 100 Employee
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QA Director
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2008 - 2008
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QA consultant
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2008 - 2008
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QA Manager
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May 2001 - Dec 2003
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QA
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1991 - 2000
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Education
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1999 - 2002
The Open University of Israel
Psychology
Community
