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
A Success Story Unfolds When the Co-founders of Neopenda, Sona Shah, CEO and Teresa Cauvel, CTO approached MAE Group they needed regulatory approval and quality system. Because their life saving product, NeoGuard, was ready for market, they came to MAE Group for their next steps. To be clear, the NeoGuard addresses a health care crisis.
Neopenda: A Success Story Unfolds Read More »
News & Blog, Success Stories
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, ServicesCongratulations! You’ve developed an idea for an innovative product. A great idea is your first step, getting it to market is the next. That’s where MAE Group comes in. We can take your prototype idea, determine how to make it a usable product, and get it safely to market. All the way from creating a
Product Development & Manufacturing Read More »
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