Since 1994, Quality and Regulatory Services, Inc. has specialized in providing FDA compliance solutions to the medical device industry and is uniquely qualified to assist you to attain and maintain your regulatory compliance and quality objectives. Our staff has direct experience working on staff in the medical device industry, in health care institutions, and at the Center for Devices and Radiological Health, U.S. Food and Drug Administration (CDRH/FDA).

Quality and Regulatory Services, Inc. is an in depth consulting firm ready to help you with a full range of customized services including management orientation to FDA and ISO 9000 requirements and the development of proactive compliance programs. We provide full support, assistance, and training in CDRH/FDA regulatory compliance areas including; IDEs, PMAs, 510(k)s, QSR/CGMP implementation and audits, responses to a FDA 483 or Warning Letter, and Radiological Health. We assist as well in ISO 13485 Quality System implementation and audits.

We help our U.S. clients take products to Europe and foreign clients bring their products to the United States. In addition, bilingual services are available in German. Our philosophy is to efficiently transfer our knowledge to your staff so that your company becomes proficient and self-sufficient in maintaining regulatory and quality compliance.

There is finally one regulatory consulting group that will cost you less because it gives you more.

The broad experience of QRS, Inc. makes it unnecessary for you to expend resources to teach us the special aspects of your devices in health care applications or the complex interrelationships of design, manufacturing, and marketing that occur in bringing a device to market while maintaining quality and regulatory compliance.

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Tel: 925-787-2421

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Quality and Regulatory Services Inc.