Our Foundation
Janet Kwiatkowski founded MAE Group in 2013 to bring life-saving devices to global markets.
With Janet as the lead, MAE Group began partnering with medical device, bioscience, and life science companies by providing global regulatory affairs, clinical affairs, quality management, and program management services to commercialize products in target markets. MAE Group continues to provide these services to start-ups and SMEs (Small and Medium Enterprises) as well as large blue-chip companies
MAE Group’s expertise lies in our in-depth knowledge of regulations and most importantly, interpretation and application of the requirements, to guide any company through the commercialization pathway to successful product launch with strategic and tactical alignment to business plans. MAE Group has established an excellent reputation with global regulatory bodies. We are honored to partner with a multitude of companies to bring devices to the world.
In 2021, MAE Group expanded the company’s vision leading the commercialization of a thermobrachytherapy oncology medical device, a platform technology, under the MAE Group brand.
Why Choose Us
We expertly guide your market entry, deliver comprehensive regulatory solutions, offer full commercialization support, provide a competitive edge for business expansion, and offer a one-stop solution for strategic growth goals.