Oracle Consulting Group

Category: Service Providers

Oracle Consulting Group is a Tucson, Arizona-based firm specializing the quality system
consulting activities to U.S. and foreign firms:
• Regulated by the U.S. Food and Drug Administration (FDA)
• Meeting various international medical device regulatory requirements
• Who have adopted or are implementing one of the ISO 9000 quality standards
• Foreign firms that require an official U.S. Agent and/or an Official Correspondent
• Who require client or marketing surveys

Oracle Consulting Group provides the following services:
• Preparing medical device manufacturers for FDA regulatory compliance and device
submissions.
• Providing U.S. Agent and Official Correspondent services to foreign firms.
• Assisting firms for their implemented IS0 9000 quality system conformance.
• Providing firms with tailored client and market surveys.
• Assisting firms with their “due-diligence” for potential acquisition of medical device
manufacturers, that is, a regulatory status assessment of the prospective acquisition to
reveal their FDA compliance status.

Oracle Consulting Group welcomes inquiries and questions about our consulting services.
We will honestly assess your quality system needs and tailor a proposal specific to those
needs. We know that you will be satisfied with both the process and the output products of
our services.

Gordon Harnack, Managing Consultant