Navigation Links
R&Q Solutions, LLC Announces Launch to Serve Region's Medical Device Industry

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:

SOURCE Regulatory and Quality Solutions, LLC
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Block Imaging International, Inc. Partners with Dicom Solutions, Inc. to Offer New Products
2. Rising Medical Solutions, Inc. Expands Its California Managed Care Services to Include Utilization Review Program
3. Medsn to Become Indegene Pharmaceutical Solutions, Inc.: Change Signifies the Success of Its Innovative Global Services Model
4. MIPSolutions, Inc. Reduces Expense and Development Time Associated With Precious Metal Extraction
5. Facet Solutions, Inc. Completes Combination Facet Joint and Disc Replacement Study
6. Facet Solutions, Inc. Appoints Industry Veteran to Board of Directors
7. Facet Solutions, Inc. Expands Executive Management Team
8. Streamline Health Solutions, Inc. Reports Fourth Quarter and Fiscal Year 2007 Results
9. Arthur J. Gallagher & Co. Acquires Healthcare Risk Solutions, LLC
10. Providence Service Corporation and UnitedHealth Group Affiliate, OptumHealth Behavioral Solutions, Enter Into Strategic Relationship Agreement
11. Rising Medical Solutions, Inc. Ranks Fifth on the Private Company Index (PCI) Top Growth Companies List
Post Your Comments:
(Date:10/12/2015)... ... October 12, 2015 , ... To help ... its charitable donation to the National Breast Cancer Foundation. The National Breast Cancer ... breast cancer through early detection, education, and support services. , The annual campaign ...
(Date:10/12/2015)... ... October 12, 2015 , ... SQM Group ... a contact channel benchmarking study. Be a part of this insightful ... for improving customer experience, customer journey, contact channel execution and intelligence, workforce optimization, ...
(Date:10/12/2015)... ... ... Holcomb – Kreithen Plastic Surgery and MedSpa, PLLC (“Holcomb – Kreithen”), one of ... Surgery University,” an educational series of mini seminars covering aesthetic and plastic surgery options, ... Saturday, October 24, 2015. , The goal of the event is to provide hands-on ...
(Date:10/12/2015)... ... October 12, 2015 , ... The Asthma and ... Engagement Award by the Patient-Centered Outcomes Research Institute (PCORI) for a new project ... , The project, entitled “Training Patients with Asthma to Understand and Participate in ...
(Date:10/12/2015)... ... October 12, 2015 , ... International law firm Greenberg ... with the U.S. Biomedical Advanced Research and Development Authority (BARDA) reported to be ... ReCell® Autologous Cell Harvesting Device under a U.S. mass casualty preparedness program. ...
Breaking Medicine News(10 mins):
(Date:10/12/2015)... New York , October 12, 2015 ... (FMI) delivers key insights on the global vital signs monitoring ... Devices Market: Global Industry Analysis and Opportunity Assessment 2015-2025." The ... at a healthy CAGR of 9.5% and 9.2% in terms ... to factors, regarding which FMI offers major insights in detail ...
(Date:10/12/2015)... Oct. 12, 2015 Beginning October 1, 2015 ... Partner, the fastest growing practice management system for therapists, ... easily converts all patient diagnostic codes from the former ... --> --> Therapy Partner has ... mental health practitioners to easily understand the conversion to ...
(Date:10/12/2015)... , Oct. 12, 2015 Indivior PLC (LON: INDV) ... of Delaware granted the Company,s motion ... Abbreviated New Drug Application (ANDA) No. 205299 to market a ... and naloxone) Sublingual Film (CIII) in the United ... Since August 2013, Indivior has received Paragraph IV certifications ...
Breaking Medicine Technology: