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R&Q Solutions, LLC Announces Launch to Serve Region's Medical Device Industry
Date:11/13/2008

A Full-Service Regulatory Firm: Sending Medical Devices to Market Faster

PITTSBURGH, Nov. 13 /PRNewswire/ -- Formed this past summer, Regulatory and Quality Solutions, LLC (R&Q Solutions) has launched its website as a final step of market entry as the region's first full-service Regulatory and Quality Assurance firm for the medical device sector. According to the 2007 State of the Industry Report from the Pittsburgh Technology Council, the medical equipment and devices industry in the Pittsburgh region alone has grown 10 percent to nearly 125 companies. These companies employ nearly 5,000 individuals in the region.

As the medical device industry continues to grow, so too does the need for quality and regulatory support. President Maria Fagan and Vice President Lisa Casavant developed R&Q Solutions with a vision aimed at effectively navigating the complexities of Federal Drug Administration (FDA) and international regulations. Fagan, Casavant and their team of trained Regulatory and Quality Professionals lead companies down the path toward product clearance, delivering safe, high-quality and effective products to market faster.

"We started talking with medical device start-ups in 2007 and found there to be a huge gap in regulatory and quality support in the Pittsburgh region," said Fagan. "Companies have had no option but to outsource to other states for regulatory expertise, stretching their teams thin in an attempt to meet quality system and design control requirements. Our experience in regulated industries and especially at Medrad crossed the spectrum of the needs of the region. We realized quickly that we could provide valuable services to local medical device companies, while building a successful service firm right here in Pittsburgh. We are so proud to contribute to the growth of Pittsburgh's life sciences industries."

"Understanding the regulatory requirements is critical to the commercialization of life sciences products,"
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SOURCE Regulatory and Quality Solutions, LLC
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