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
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Keywords
medical device qualitytechnical documentationfdasoftwareauditingproject managementcomplianceregulatory compliance for medical devicesqsrmedical device manufacturingprocedurestrainingiso13485articifical intelligenceiso62304validation verificationiso14971risk managementmedical equipment manufacturinginformation technology & servicesproductivitymedical deviceshospital & health care
Company Information
- Employees0
- Founded2006
Location
1236 Main St, Ramona, California, United States, 92065-2125
