About
We are a RESULTS driven firm with 20 years of Quality & Regulatory Consulting and Industry experience, driving Simplified and Defensible Regulatory strategies for compliance in Medical Device/IVD Manufacturing, SW Development, Operations and R&D. We are skilled at working in the grey zone of Quality and Regulatory Compliance! Focusing on Patient Safety using a Risk-based approach in the Design and Development of Medical Devices/IVD.
Technologies
Outlook
GoDaddy Hosting
Keywords
medical device quality
technical documentation
fda
software
auditing
project management
compliance
regulatory compliance for medical devices
qsr
medical device manufacturing
procedures
training
iso13485
articifical intelligence
iso62304
validation verification
iso14971
risk management
medical equipment manufacturing
information technology & services
productivity
medical devices
hospital & health care
Company Information
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Employees 0
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Founded 2006
Location
1236 Main St, Ramona, California, United States, 92065-2125
