| Quality and Regulatory Services, Inc. provides FDA compliance solutions to medical device manufacturers. |
Quality and Regulatory Services, Inc. helps U.S. clients take medical devices to Europe and foreign clients bring medical devices to the U.S.A.
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Quality and Regulatory Services, Inc. provides support, assistance, and training for all Center for Devices and Radiological Health/FDA compliance needs including:
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QSR/CGMP implementation and audits |
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Product and process validation for hardware and software. |
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Investigational Device Exemptions (IDEs) |
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Premarket Approval (PMAs) |
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Premarket Notifications (510(k)s) |
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FDA 483 or Warning Letter recovery |
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Radiological Health |
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ISO 13485 implementation and audits |
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| CONTACT QUALITY AND REGULATORY SERVICES, INC. |
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Tel: 925-787-2421 Email: |
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Quality and Regulatory Services Inc.
