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…
When the Co-founders of Neopenda, Sona Shah, CEO and Teresa Cauvel, CTO approached MAE Group they needed regulatory approval and quality system. Their life saving product, NeoGuard, was developed, manufactured, and ready for market. They came to MAE Group for…
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…
Jay Wigley, Manager QA/RA 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 and…
Janet Kwiatkowski, CEO, found MAE Group in in 2013 in order to provide innovative and life saving devices to the world. Being different makes a difference. That’s why I began MAE Group, to use my own outside-the-box thinking to help others…
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…