What is risk-based thinking in the medical device industry? Why is it essential? Around 4,500 drugs and medical devices are pulled from shelves across the United States each year. This alarming statistic highlights the importance of controlling and mitigating risk…
It’s rare for a small Medical Device business services provider to take on the commercialization of their own medical device. And that sort of challenge is not at all what Janet Kwiatkowski (CEO of MAE Group) intended when she founded…
Growing your team to be the best and most effective seems challenging especially as an executive, manager, or team leader. However, by using the model of a growth mindset, a company and team becomes the most effective and integrated team…
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…
MAE Group’s CEO Janet Kwiatkowski and Jay Wigley, Manager of QA and RA participated in one of the premiere summits in the medical device industry. For over twenty-five years the Marcus Evans Group has provided the world’s leading organizations conferences,…
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…
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…
Discover the purpose of a quality management system in the medical device industry.