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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…

Neopenda Success Story: A Truly Life Saving Device

When the Co-founders of Neopenda, Sona Shah, CEO and Teresa Cauvel, CTO approached MAE Group they needed regulatory approval and quality system. Their life saving product, NeoGuard, was developed, manufactured, and ready for market. They came to MAE Group for…

Getting FDA Approval, Step-by-Step

First, congratulations on creating a marketable and perhaps life saving device. Now, it’s time to get your product safely and effectively to market. But first you’ll need FDA clearance or approval and that requires getting through the FDA application process.…

What is a Design History File? Begin Here.

Why Do You Need a Design History File? In short, the FDA requires a Design History File (DHF) as part of the application and marketing process for medical device manufacturers. First required by the United States FDA in 1990 as…

A Marketable Medical Device: Your Step-by-Step Guide

At first turning a concept into a marketable medical device feels daunting. Your great idea solves a critical concern in the health care field, however, the concept itself comprises the first step among many to getting your innovative product safely…

Get Your Product to Market on Time and Within Budget

So you want to release your medical device or pharmaceutical product into the US or global market for your company expansion goals. Perhaps you are already behind on the timeline and over your budget. In order to get your product…

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

About Us

Founded in 2013, 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…

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…