About
Over 17 years of proven experience in the Medical Device industry, offering a variety of quality assurance & regulatory affairs consulting services customized to fit your specific needs. We provide a comprehensive approah to the medical device market including the tools, guidance, and support you need to succeed.
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Keywords
quality assurance
iso 13485
cfr 21 part 820
ce marking
regulatory affairs
medical device
mdsap
medical equipment manufacturing
regulatory strategy
regulatory consulting
regulatory process optimization
supplier audits
capa handling
regulatory project support
technical file creation
iso 13485 certification
eu mdr compliance
services
regulatory process
qms setup
product registration
risk mitigation
regulatory guidance
medical device technical files
regulatory strategy development
regulatory training
regulatory gap assessment
eu mdr
regulatory support
regulatory submissions
Company Information
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Employees 1
Location
Petah Tikva, Center District, Israel