FDA COMPLIANCE SOLUTIONS SINCE 1994

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:

      
QSR/CGMP implementation and audits
Product and process validation for hardware and software.
Investigational Device Exemptions (IDEs)
Premarket Approval (PMAs)
Premarket Notifications (510(k)s)
FDA 483 or Warning Letter recovery
Radiological Health
ISO 13485 implementation and audits

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CONTACT QUALITY AND REGULATORY SERVICES, INC.
Tel: 925-787-2421
Email:

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Quality and Regulatory Services Inc.