Ushering Clients into the Future of Software and AI/ML
Design high-performing, innovative, secure, and compliant SaMD and SiMD products to drive market capture and improve patient outcomes.
Software is an essential part of advancing patient outcomes
Software as a Medical Device (SaMD) is broadly defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
No matter where you are on your SaMD journey, we can help!
Our team of experts help our clients define development, regulatory, and commercialization strategies for SaMD.
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Leverage our deep expertise to quickly identify a path to SaMD compliance.
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Learn best-practice strategies to expedite your SaMD product approvals.
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Commercialization of SaMDs presents unique challenges. Leverage our experience and avoid costly mistakes and expedite market penetration.
Still learning about SaMD?
Review this expanded definition of what products are considered SaMD.
