According to a recent State of the Industry Report by the Pittsburgh Technology Council, the medical equipment and devices industries in the Pittsburgh region alone has grown ten percent to 125 companies. These companies provide employment for nearly 5,000 men and women in the Pittsburgh region. As the medical device industry continues to grow, so too does the need for regulatory and quality support. Officially launched on July 1, 2008, Regulatory and Quality Solutions LLC (R&Q Solutions), became the region’s first full-service regulatory and quality assurance firm. President, Maria Fagan, and Vice President, Lisa Casavant developed the company with a vision aimed at effectively navigating the complexities of FDA and international regulations. Fagan, Casavant, and their team of trained Regulatory and Quality Professionals lead companies down the path to product clearance, sending safe, high quality, and effective products to market faster.
It is crucial for developing medical device companies with limited resources to understand the most efficient path to commercialization. FDA and international requirements can cripple a developing company if it lacks the necessary regulatory support. Often, seed companies are unaware of the complexities and resource requirements associated with the quality system and regulatory strategy development necessary to properly launch a safe and effective product. Offering guidance and services in support of Regulatory Strategies and Submissions, Quality System Development, Safety Risk Management, Clinical Trial Management, Product Quality Assurance, and Verification and Validation, our team guides new medical device companies to market efficiently.
Initial regulatory guidance points a company in the right direction, but team integration of regulatory and quality assurance expertise must be maintained to ensure success. Our team provides product development companies with on-site support to optimize regulatory and quality assistance. Our staff joins the team as integral members with services such as Regulatory Officer Retention, Quality System Leadership, Acquisition Integration Leadership, and Post-Launch Product Support.
R&Q Solutions aims to grow the medical device industry, especially in the Greater Pittsburgh Area. As native Pittsburgh residents, our team is dedicated to serving our region by contributing to the growth, profitability, and success of medical device companies, bringing pride to our great city. To achieve this goal, we are focused on delivering results to jumpstart the progress of new companies and facilitate the continued advancement of existing companies.
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