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Software as a Medical Device

Digital health is a rapidly growing market driven by a need for more efficient and cost-effective healthcare, increasingly pushed towards remote monitoring and out of hospital care with the promise of better outcomes through personalized medicine.

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.

What we do

Capture high potential opportunities for sustainable growth

Understand the market and create value-driven solutions leveraging robust technology to meet business and end-user needs.

Create seamless and engaging user experience ensuring safety and ease-of-use

Apply best practices in Interaction Design and Human Factors Engineering to engage and support users.

Accelerate time-to-market with SaMD solutions built to grow with evolving needs

Framework and certified processes to rapidly design, iterate and maintain compliant, engaging solutions.

Build and scale your capacity to capture and manage medical data.

Design, customize, deploy platforms for reliability, security, growth and flexibility to meet future needs.

AI solutions trusted by HCPs and accepted by regulators

Unlock value of data with AI solution design, implementation, verification and lifecycle support.

Ensure security by design

End-to-end system security to manage threats and assure health data compliance.

Simplify compliance – from regulatory strategy to submissions and post-market support

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.

Meet our experts

Andrew Koubatis

Intelligent Medical Products and Systems Lead, Capgemini Engineering
Providing Pharma and MedTech with service offers to accelerate and de-risk product development. “Intelligent products and systems allow us to break the traditional boundaries of the healthcare ecosystem, providing greater patient insights through data, more effective, reliable and personalized treatments, driving better outcomes and supporting value-based care with connected and interoperable technologies.”