MAE Group offers target services and expertise that translate into an efficient and economical fast-track to global markets. Whether your company is your company is experiencing a bandwidth shortfall or you need a specific skill set, MAE Group offers you that expertise. Trust MAE Group to handle every aspect of independent regulatory, quality systems, design […]
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Solutions
Goal Project goal was to research and determine regulatory strategy to market a mobile medical app as a diagnostic aid to determine level of cognitive functioning. Background A European startup company developed a mobile device app known as Standardized Mental Capacity Assessment. This app is intended as a diagnostic aid to determine level of cognitive
We’ve all seen it on television: a careful, methodical turtle taking one cautious step at a time. Very. Slowly. Meanwhile, a rabbit nearby is rushing, then maybe napping, but always losing the race. We might cheer for the turtle or the rabbit, but we all know who wins in the end. The turtle, of course.
Medtech Rushing Wastes Time Read More »
News & Blog
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. In the climate of innovation in the health and medical device industry, thinking outside the box as a service provider matters.
Being Different Makes a Difference Read More »
News & Blog
First, being a key decision maker and leader in any company becomes a challenge when you don’t have the bandwidth. Whether it’s an expansion of tasks due to company growth or new demands on your own time, you need to get out of overwhelm. The burden of trying to do more and be more. There
MAE Group Gets You Out of Overwhelm Read More »
About Us, News & BlogTruth be told, medical device startups make preventable mistakes. Learn first how to avoid the common mistakes mitigating disaster, saving time, and preventing costly delays. This article breaks down why medical device startups make these mistakes. Then, we’ll outline how to prevent and mitigate them. In short, this article outlines the top mistakes made by
Top Mistakes Made by Startups Read More »
News & Blog
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 part of the Safe Medical Devices Act, the DHF contains all the product development documentation
What is a Design History File? Read More »
News & Blog, Resources
Discover the purpose of a quality management system in the medical device industry.
Quality Management Demystified Read More »
Services
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 to market. The next critical steps turns that medical device into a physical product. So
Getting a Medical Device to Market: A Step-by-Step Guide Read More »
Resources, Services
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 to market on time and within budget you need an expert. The Challenges of Getting
Getting your Product to Market on Time Read More »
Resources, Services