Maria Fagan, President of RQM+, Most Influential WomenLeaders of 2021 Profile

Maria Fagan
President of RQM+

Maria Fagan, President of RQM+, Most Influential WomenLeaders of 2021

“Improving Lives with Dedication”

Maria Fagan has always had an entrepreneurial mindset. While working for a large medical device manufacturer, she identified a great need in the device industry for regulatory affairs and quality assurance consulting services. Maria saw this as an opportunity to start a small business that would help the industry while creating a rewarding and flexible place to work. In 2008, Maria joined forces with her colleague, Lisa Casavant, to create RQM+. Now thirteen years later, Maria is President and CEO of a team of over 450 employees.

“RQM+ is the world's largest regulatory and quality consulting firm focused on medical devices and diagnostics. We deliver transformative solutions by providing an unrivaled collective knowledge, fueled by passion for client success.”

From day one, most of Maria’s leadership team members were women from the medical device industry who wanted to have more control over their careers and work-life balance. Maria gave them the flexibility they needed to put their families first while empowering them to be their best in their careers. Maria also found an incredible untapped candidate pool with female engineers who wanted to limit work to during school hours while raising their young children. Medical device manufacturers would rarely allow part-time employment, so these women were forced to make the choice between their careers and having more time at home. Maria was happy to hire these part-time working mothers and never saw it as a risk. These employees are smart, focused, and driven to be successful in both work and at home, and the results prove it. Every RQM+ client utilizing the part-time employees has stated that they accomplish more in a week than many of their full-time employees.

Although there have always been far more women working at RQM+ than the typical engineering-based firm, it was never Maria’s intent to hire one gender over another. “The men at RQM+ are equally fantastic. RQM+ just attracts and retains more women than is typical thanks to its supportive and flexible culture,” Maria shared. “Living by the golden rule - treating people the way you’d like to be treated - is just one of the core values we implemented in year one. People will follow a leader that has their best interest at heart. And when both women and men are given the opportunity to balance everything important in their lives, they are even more inspired for greatness in their careers.”

Maria founded RQM+ to improve people’s lives - the lives of their clients, their employees, and most importantly the patients using the devices they support. Maria and her team initially focused on the smaller start-up medical device companies because there was no support for them in the regulatory and quality service space. Regulatory affairs and gaining market entrance to the U.S. and EU are extremely challenging, and small companies with amazing product ideas often don’t know where to start. RQM+ began with these companies and quickly found that even the largest device manufacturers in the world had the same challenges and needed their support. RQM+ continually expanded in a measured fashion to be the large global entity that it is today.

A key to success during the company’s rapid growth was Maria’s continued focus on strategic planning and not diluting the strategy with the service need of the day. As they grew both geographically and in volume, Maria ensured they stayed true to their vision and mission. “Our vision is 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 customer service and employee satisfaction delivered with empathy, integrity, individual pride, and company spirit.” Maria continues, “We’ve never strayed from our core expertise of regulatory and quality assurance. Dedication to our vision, mission, and strategic plan ensures we’ll hire and retain the best employees, provide an incredible place to work, and deliver outstanding services to the industry.” IEWL




Maria Fagan
President of RQM+


R&Q and Maetrics have merged to become RQM+, the largest medical device and diagnostics focused full-service regulatory and quality consulting firm in the world. The integration of our leadership teams and extensive skills and experience of our collective resources have created a highly agile, scalable, and global organization.

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