Regulatory and Quality Solutions (R&Q)—a regulatory and quality consulting service for medical devices, in vitro diagnostic devices (IVDs), and combination products— has acquired Maetrics, a life sciences quality and regulatory consulting firm.
Maria Fagan, R&Q president, said: "R&Q’s vision has always been to become the worldwide 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 across the globe. We’re excited to take a critical step toward achieving our vision by adding Maetrics’ leadership, skills, experience, and global footprint. Together, we will improve even more people’s lives with our highly scalable organisation.”
Together, R&Q and Maetrics offer specialist consultancy services to the medical device, diagnostics, and pharmaceutical industries:
- Full-service suite of regulatory and quality solutions, including regulatory strategy and submissions, quality systems, safety risk management, and process validation.
- Implementation of new regulations, including the EU MDR and IVDR and creation of CERs and PERs, overseen by a former notified body leadership expert on staff.
- Clinical practice supporting EU requirements, providing strategies and turnkey approach 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.
- Project management by certified project managers who are seasoned device professionals focused on RA/QA.
- An international footprint, including offices in the United States and a European headquarters based in Nottingham.
Maetrics president Steve Cottrell said: “We are thrilled to be part of R&Q. Together, we provide a truly unique consultancy offering to the life science industry. With our combined capabilities, clients know they are working with a leading partner that they can trust to deliver. The healthcare sector is so important to our everyday lives—now more than ever—and both R&Q and Maetrics are dedicated to continually supporting this mission with our effective regulatory and quality solutions.”
