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 […]
Blue Chip Solutions Read More »
Solutions
Goal The project goal was to lead the global recall of Post-Operative Knee Brace medical device Background A US-based orthopedic rehabilitation products company designs and manufactures, a knee brace intended to control the range of motion at the knee joint following surgeries and other structural repairs. Due to a failure in the mechanical hinge, the
Recall Resolution: MAE Group’s Strategic Approach to Knee Brace Safety Read More »
Regulatory Affairs, Success Stories
Regulatory device compliance
3 Keys to Understand Regulatory in Med Device Read More »
News & Blog
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 in the medical device industry. For years regulatory guidance and standards like ISO 14971 have
What is risk-based thinking in the medical device industry? Read More »
News & Blog
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 the company in 2013. Her original intention was more focused on helping other companies provide
A Journey of Hope: The Story of a Small Company with a Big Vision Read More »
News & Blog, Project Hope
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 possible. A growth mindset is the belief or view that the brain can grow. A
How to Amplify your Team Read More »
News & Blog
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 & Blog
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, summits, and professional training. The Marcus Evans Medical Device Summit leads the industry in providing
Summit Offers MAE Group Opportunities to Expand its Vision Read More »
News & Blog