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Quality System Services

MAE Group quality professionals make sure that your company and devices are in compliance to applicable quality system standards and regulations. A compliant quality management system is the backbone of any company and crucial in ultimately gaining regulatory clearance or…

Program and Project Management

Project management in the drug, medical device and biotechnology industry is the management of various disciplines to achieve one goal: to bring your product to the market within the budgeted project costs, with the available resources and within the agreed…

MAE We Help?

Your one-stop resource location for information and resources. How MAE We Help? Getting FDA Approval, Step-By-Step What’s a Design History File? What is a Quality Management System? A Marketable Medical Device: Your Step-by-Step Guide What is Risk-Based Thinking in the…

Early Stage Solutions

MAE Group is the capstone between the inventor and investor. We offer a full bespoke suite of commercialization services to early-stage companies. Our teams will efficiently get you through the commercial process, maximize the inventor’s exit strategy, and de-risk the…

Our Story

Janet Kwiatkowski, CEO, found MAE Group in in 2013 in order to provide innovative and life saving devices to the world, yet it’s become so much more. Being different makes a difference. That’s why I began MAE Group, to use my…

MAE Group Leading Development of Thermobrachytherapy Oncology Medical Device

MAE Group is leading the development of a thermobrachytherapy oncology medical device, a platform technology, under the MAE Group brand. As the name implies Project Hope offers hope to patients and their families impacted by glioblastoma (GBM) and other brain…

We Bring Lifesaving Products to Global Markets. Global. Commercial. Partner.

About Us

Janet Kwiatkowski founded MAE Group in 2013 in order 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,…

Services

MAE Group is a business service provider specializing in domestic and international Regulatory Affairs, Clinical Affairs, Project Management and Compliance services to healthcare companies to commercialize medical and in vitro diagnostic devices in target markets. MAE Group can assist your company gain…

Solutions

Early Stage Solutions MAE Group is the capstone between the inventor and investor. We offer a full bespoke suite of commercialization services to early-stage companies. Our teams will efficiently get you through the commercial process, maximize the inventor’s exit strategy, and…