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
OutlookActive CampaignTypekitGoogle Tag ManagerAIRemoteIntuitCircle
Keywords
medical equipment manufacturingmedical equipment and supplies manufacturingfda audit preparationqms iso 13485regulatory project managementfda registrationregulatory pathway optimizationquality management systemfda approval processmedical device complianceregulatory submissionsmedical device registrationpremarket approval (pma)fda compliance trainingmedical device lifecycle managementinvestor risk assessmentclinical study supportrisk managementpre-submission meetingsiso 9001:2015medical device regulationproduct developmentfda approval accelerationregulatory consultingmanufacturingb2bfda communicationfda complianceregulatory documentationregulatory process automation
Company Information
- Employees1
Location
New York, New York, United States
