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Software as a Medical Device (SaMD) is the regulated sub-segment of digital health solutions, including digital therapeutics (DTx).
Industry demands are accelerating convergence of digital health technologies, combining patient centric applications with telehealth and HCP dedicated apps as part of a holistic healthcare ecosystem, but also increasing complexity.
Accelerating technological change has created new ways for providers to engage with patients, creating a need to deliver SaMD solutions quickly to maintain market relevance thereby challenging the traditional business models.
Secure and flexible foundations for medical apps.
Understand the market and create value-driven solutions leveraging robust technology to meet business and end-user needs.
Apply best practices in Interaction Design and Human Factors Engineering to engage and support users.
Framework and certified processes to rapidly design, iterate and maintain compliant, engaging solutions.
Design, customize, deploy platforms for reliability, security, growth and flexibility to meet future needs.
Unlock value of data with AI solution design, implementation, verification and lifecycle support.
End-to-end system security to manage threats and assure health data compliance.
We can act as Legal Manufacturer to reduce your compliance efforts. We can also help you develop your capability to become Legal Manufacturer and support your immediate regulatory needs.
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