MAE Group

Small & Medium Enterprise Solutions

Whether you’re a small or medium size enterprise, MAE Group Solutions has you covered. MAE Group provides comprehensive regulatory, quality, design, clinical, and project management expertise to see your product through to final clearance or approval. We assist in the global commercialization of medical and in vitro diagnostic devices, OTC and Pharma Rx.diagnostic devices, OTC and Pharma Rx.


MAE Group has evaluated and provided guidance on all aspects of regulatory strategy for our product development. They are a very proactive group that knows time is money, that is why their responsiveness is highly effective.

Gonzalo Ladreda, CEO POCKiT diagnostics

From leading pre-market strategy to ensuring post-market compliance and all of the regulatory submissions in between, MAE Group supports companies throughout the product life cycle. Our focused, professional team provides comprehensive and responsive expertise to navigate your product from early development thorough final approval.


No other service provider has the expertise and strategic alliances that allow you to realize the full potential of your product and business. MAE Group offers target services and expertise that translate into an efficient and economical fast-track to global markets.


As a client of MAE Group, we have contracted with them for multiple projects which were always done professionally and on time. We especially were impressed with their overall knowledge of the regulatory field and their structured and communicative approach to the projects at hand.

Mark J. Lewis, VP Operations and RA HydroCision Inc

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