Together, the two organisations form the largest agile and highly scalable consulting firm dedicated to their combined focus areas in the life science industry.


Regulatory and Quality Solutions acquires Maetrics to form largest medical device-focused global regulatory and quality consultancy. (Credit: Akshay93 from Pixabay)

Regulatory and Quality Solutions LLC (R&Q)—a leading provider of regulatory and quality consulting services for medical devices, in vitro diagnostic devices (IVDs), and combination products—today announced that it has acquired Maetrics LLC, an international leader in life sciences quality and regulatory consulting.

Together, the two organizations form the largest agile and highly scalable consulting firm dedicated to their combined focus areas in the life science industry.

“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,” said the company’s 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 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 organization.”

“We are thrilled to be part of R&Q,” said Maetrics President Steve Cottrell. “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.”

Fagan, an original founder of R&Q, claims her favorite quote perfectly describes the integration of R&Q and Maetrics: “The whole is greater than the sum of its parts.” In alignment with this quote, the teams from both companies have rallied around the integration tagline of being “Stronger Together.” As the companies continue to unite, the combined leadership team aims to continue its mission to enhance the lives of patients, clients, and employees. The two companies have found a very natural fit when working on client programs together. Their similar focuses on culture and aligned vision have already created successes for clients and team members alike.

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.

Expert implementation of complex new regulations, including the EU MDR and IVDR and creation of CERs and PERs, overseen by a former notified body leadership expert on staff.

Strong 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.

Best-in-class project management by certified project managers who are seasoned device professionals focused on RA/QA.

An international footprint to serve client’s needs, including several offices in the United States and a European headquarters based in Nottingham, England.

Source: Company Press Release