About
Consulting Company specializing in Regulatory Affairs and Quality Assurance for regulated industries. Specialties include: Start-ups Medical Devices In Vitro Diagnostics (IVD) Regulatory Affairs Quality Assurance Regulatory Submissions International Submissions US FDA MDR IVDR
Technologies
Android
Remote
AI
IoT
Node.js
Keywords
regulatory affairs
combination products
fda
mdr
design dossier
ivdr
iso 14971
international
pma
510
regulatory submissions & documentation
medical device
quality assurance
21 cfr
quality management systems
iso 13485
technical files
ivd
medical equipment manufacturing
hospital & health care
medical devices
Company Information
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Employees 6
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Founded 1996
Location
420 Gateway Dr, Pacifica, California, United States, 94044