Get to market faster with our expert services.
You need a software-development partner for a new or existing medical-device product.
You need to determine the best path to the US market or have other custom regulatory needs.
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Empower medical device innovation with our solutions for particular business situations.
We guarantee AI/ML SaMD FDA submission and clearance in 9 months.
FDA identified major cybersecurity, software, or AI/ML deficiencies that you need help resolving.
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You need Quality Management System implementation and/or support.
You need a product-development partner for an AI-enabled imaging application.
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Joined: June 15, 2026
