MONROEVILLE, Pa. In September of 2020, Regulatory and Quality Solutions LLC (R&Q) announced its acquisition of Maetrics LLC. The strength and size of the combined companies deserved new branding, and the new company name RQM+. As RQM+, the two companies – which will continue the strong service offerings previously available through R&Q and Maetrics – now form the largest agile and highly scalable consulting firm dedicated to serving global medical device and diagnostics manufacturers. Rebranding as RQM+ is an indicator of the organization’s expanded geographical reach across the US, Europe, and beyond.
“The vision has always been to extend our global footprint as the leader in providing full-service regulatory and quality solutions to the medical device and diagnostic industries,” said RQM+ President, Maria Fagan. “Our exceptional business-balanced solutions and leadership have been key to accelerating the success of life science companies and ultimately improving the lives of people everywhere. We have merged R&Q’s and Maetrics’ services and operations and are excited to take the next step of rebranding, to demonstrate the incredible capabilities of our combined companies. Together, as RQM+, we will assist our clients in improving even more people’s lives with our highly scalable service offerings and a truly global footprint.”
Fagan, an original founder of R&Q, says that the teams from both companies have rallied around the integration tagline of being “Stronger Together” and the new vision and mission for RQM+:
To be the world’s most trusted and valued partner in providing transformative regulatory and quality solutions to medical device and diagnostics manufacturers.
We are dedicated to the highest levels of client service and employee satisfaction delivered with empathy, integrity, individual pride, and company spirit.
The two companies have found a very natural fit when working on client programs together, as their service range, vision, and culture have been so similar, both in principle and in practice – creating successes for clients and team members alike.
RQM+ provides global coverage across a range of specialist consultancy services to medical device and diagnostics manufacturers:
- Full-service suite of regulatory and quality solutions, including regulatory strategy and submissions, quality systems, safety risk management, and process validation.
- Expert implementation of complex new regulations, including complete transition solutions for the EU MDR and IVDR.
- Strong clinical practice supporting EU requirements, providing clinical/regulatory strategies and turnkey approaches to completion of CERs, PERs, and PMS-related
- deliverables (PSUR, SSCP, PMCF/PMPF plans and reports, PMCF/PMPF surveys), led by the former BSI Global Head of Clinical Compliance.
- Strategic regulatory compliance consulting to support businesses at the highest levels, usher in effective compliance strategies, support innovation and growth initiatives, and embed a culture of compliance.
- Regulatory finding response management, providing best practice strategic, tactical, and creative solutions to address NB nonconformity reports, as well as FDA 483 findings, warning letters, and consent decrees, with a highly scalable team for remediation programs.
- Best-in-class project management by certified project managers who are seasoned device professionals focused on RA/QA.
- An international footprint to serve clients’ needs, including several offices in the United States and a European headquarters based in Nottingham, England.
For more information on the integrated company, visit RQMplus.com.
To read or download the press release, click here.
RQM+ is the world’s leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations.
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