About
Genius Shield is your medical device regulatory and quality readiness strategic partner. We de-risk innovators and investors, helping them develop and launch safe and effective medical solutions to the market. We help you navigate FDA regulation and compliance of medical device product development. Our team of savvy Regulatory/Quality/Product Development experts, comes from the top 500 Fortune medical device companies and has an accumulative 80 years of experience in the regulatory and compliance industry. We ensure that no stone is left un-turned because our priorities are your success, as well as the well-being of people globally.
Technologies
Outlook
Active Campaign
Typekit
Google Tag Manager
AI
Remote
Intuit
Circle
Keywords
medical equipment manufacturing
medical equipment and supplies manufacturing
fda audit preparation
qms iso 13485
regulatory project management
fda registration
regulatory pathway optimization
quality management system
fda approval process
medical device compliance
regulatory submissions
medical device registration
premarket approval (pma)
fda compliance training
medical device lifecycle management
investor risk assessment
clinical study support
risk management
pre-submission meetings
iso 9001:2015
medical device regulation
product development
fda approval acceleration
regulatory consulting
manufacturing
b2b
fda communication
fda compliance
regulatory documentation
regulatory process automation
Company Information
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Employees 1
Location
New York, New York, United States
