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About
FDA RA Group is a regulatory affairs and quality consulting firm supporting medical device, IVD, diagnostic, digital health, and healthcare companies throughout the product lifecycle.
FDA RA Group provides hands on support for FDA regulatory strategy, 510(k), De Novo, PMA and PMA supplement submissions, FDA Pre Submission meetings, quality management systems, ISO 13485, FDA QMSR compliance, design and change control, supplier quality, audits, inspection readiness, remediation, post market requirements, and ongoing regulatory and quality support. Our team brings practical industry experience to each engagement. We work with established manufacturers, startups, growing compani...
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Services
FDA Regulatory Consulting
Medical Device Regulatory Affairs
IVD Regulatory Consulting
FDA 510(k) Submission
FDA PMA and PMA Supplement Support
FDA De Novo Submission Support
FDA Pre Submission Meeting Support
Regulatory Strategy and Market Access
FDA QMSR Compliance
ISO 13485 Quality Management Systems
Quality System Development and Remediation
FDA Inspection Readiness
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Contact
Service Areas
- Dallas, TX, USA
Current Hours
- Sun CLOSED
- Mon 9:00 AM - 4:00 PM
- Tue 9:00 AM - 4:00 PM
- Wed 9:00 AM - 4:00 PM
- Thu 9:00 AM - 4:00 PM
- Fri 9:00 AM - 3:00 PM
- Sat CLOSED
-
Tue 9:00 AM - 4:00 PMOPEN NOW
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Detailed Information
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- sales FDA RA Group
- Phone (888) 354-1334
- Email [email protected]