Clearance letter

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 own outside-the-box thinking to help others bring life-saving devices into the world. In other words, …

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Marketing Your Medical Device Globally and Export Compliance

Congratulations – you just received your Clearance Letter from the FDA after months of hard work by a team of dedicated professionals. That Clearance Letter, the CE Marking, and ISO 13485 Certification are the gateway to international markets. You can now move forward to submit dossiers and market your product globally. As you look to …

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