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…
Blue Chip Solutions
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…
We’re Growing! MAE Consulting Expands to Europe
MAE Consulting Group of the United States and now the United Kingdom, is a business service provider specializing in offering domestic and international regulatory, clinical and compliance services to healthcare companies. With expertise in commercializing medical and in vitro diagnostic devices, MAE Consulting can…
Changes expected with the Indian Medical Device Regulations
The government of India is planning to develop an in-depth regulatory framework for medical devices. The current system lacks distinctive regulatory system and medical devices are either regulated as drugs or are unregulated. Medical devices that are regulated are under…