In September of 2020, Regulatory and Quality Solutions LLC (R&Q) announced its acquisition of Maetrics LLC, and has led to the two companies being rebranded as RQM+.
As RQM+, the two companies – which will continue the service offerings previously available through R&Q and Maetrics – now form a consulting firm dedicated to serving global medical device and diagnostics manufacturers. Rebranding as RQM+ is an indicator of the organisation’s expanded geographical reach across the US, Europe, and beyond.
RQM+ president Maria Fagan said: "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. 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.
- To be dedicated to the highest levels of client service and employee satisfaction delivered with empathy, integrity, individual pride, and company spirit.
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.
- Implementation of complex new regulations, including complete transition solutions for the EU MDR and IVDR.
- 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, 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.
- 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.
