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…
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…
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…
Truth 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…
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…
Discover the purpose of a quality management system in the medical device industry.
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…
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…
MAE Group Team
Jay Wigley, Quality Affairs Manager Mr. Wigley has over 20 years of quality assurance and regulatory leadership experience at Fortune 500 and start-up companies. Jay is experienced at designing and implementing quality systems in compliance with 21 CFR 820, 210…
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…