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,” said John W. Manzetti, President and Chief Executive Officer of the Pittsburgh Life Sciences Greenhouse. “Regulatory expertise and proper implementation of a quality system and design controls can be the difference between product success and failure and the ongoing viability of a medical device company.”
R&Q Solutions serves medical device companies in the Western Pennsylvania and Eastern Ohio Regions, as well as their suppliers. The company provides on-site, concise, and complete service from an idea’s conception to fulfillment of vision. R&Q Solutions offerings include, but are not limited to training and/or service in the following areas: regulatory, regulatory officer retention, quality system leadership, safety and risk management, clinical trial strategy and management, product quality assurance, verification and validation, acquisition integration leadership, post-launch product support, and venture capitalist due diligence.
R&Q Solutions Leadership
President - Maria Fagan: During her employment at one of Pittsburgh’s top medical device companies, Medrad Inc., Fagan progressively worked into leadership roles in quality assurance and regulatory services. As Manager of Quality Assurance for New Products, Fagan led a team of professionals that provided a broad range of quality and regulatory services to product development teams. Fagan most recently operated as the Director of Quality Assurance and Regulatory Affairs for all European offices. Fagan holds a B.S. in Mechanical Engineering from the University of Pittsburgh.
Vice President of Operations - Lisa Casavant: Holding an M.S. in Mechanical Engineering, Casavant continued to develop her skills in the Biomechanical field. Her science background propelled her into the ever-growing regulatory industry. Casavant’s ten years of industry experience included regulatory and quality leadership and worldwide submissions for product development teams at Medrad, Inc. Casavant also has extensive training in problem solving, troubleshooting, and rational analysis.
R&Q Solutions Web Site: www.raqasolutions.com
CONTACT: Robert A. Markley, Jr. of Regulatory and Quality Solutions, LLC,
+1-412-719-8280, rmarkley@raqasolutions.com
Web site: http://www.raqasolutions.com/
