MedQ Systems offers the expertise to identify critical operational elements of each biomedical technology business that are essential for aggressive time-to-market performance. Our expert management team can develop and integrate these elements within the unique characteristics of your organization, its products/services, and its overall business strategy.

If a product is commercialized without this basic integrated systems approach, its performance in the marketplace is likely to be substandard and subsequent improvements are costly. Also, the evolution of its technology to improved versions and to other products is usually difficult without reconstructing the areas of weakness or sometimes even starting over.

For example, the MedQ Systems approach can help to achieve these characteristics of success:
  • Product design assurance with sound linkage to customer requirements
  • Complete and functional design documentation that assures such capabilities as launch timeliness, outsourcing, design enhancement, and cost reduction
  • Clinical studies that help justify reimbursement
  • Strong strategic supply chain development that avoids component shortages, obsolescence, or complete supply failure.
  • Thorough but practical manufacturing process characterization and validation that prevents product performance failures and even field corrective actions
  • Thorough product and process risk assessment that guides resource focus during design and design transfer activities
  • Effective awareness, communications, and coordination with key regulatory agencies that minimizes time to marketing approvals and strengthens compliance position.
Regardless of business size, development stage, or technology, MedQ Systems expertise can add value to your business development efforts. By combining its seasoned management with a network of strategic partners and associates, we guide clients to improve operating performance, reduce time-to-market, and resolve FDA/regulatory compliance issues.


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