Janet Kwiatkowski, CEO, found MAE Group in in 2013 in order to provide innovative and life saving devices to the world.
Being different makes a difference. That’s why I began MAE Group, to use my own outside-the-box thinking to help others bring life-saving devices into the world. In other words, bring purpose into my business.Janet Kwiatkowski
MAE Group began by providing global regulatory affairs, clinical affairs, quality management, and program management services to medical device, in vitro diagnostic, bioscience and life science companies to commercialize products in target markets. MAE Group continues to provide these services to start-up and SME (Small and Medium Enterprises) as well as large blue-chip companies. We continue the vision of bringing life saving devices to global markets.
As the needs grew so did MAE Group. We expanded service in 2017 to offer a full suite of commercialization services to medical device and IVD start-up companies, from market research to initial product launch in target markets. MAE Group expertise lies with 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.
In 2019, MAE Group expanded the company’s vision leading the commercialization of a thermobrachytherapy oncology medical device, a platform technology, under the MAE Group brand. Titled “Project Hope”, the platform technology offers hope to patients and families impacted by glioblastoma and other forms of cancer.
MAE Group offers target services and expertise that translate into an efficient and economical fast-track to global markets. Janet Kwiatkowski’s vision of bringing life saving devices to global markets is evident in the business service side and leading the commercialization of a platform teaching.