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Solution

Software as a Medical Device

Connected 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 connected 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. Real World Data combined with advanced analytics and AI are revealing patient insights, driving better outcomes and enabling personalized, value- driven care.

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.

Research and insights

Capgemini Research Institute

Generative AI in cybersecurity

capgemini-research-institute
Capgemini Research Institute

World Cloud Report – Financial Services 2025

capgemini-research-institute
Point of view

Compliance: the connected product’s best friend
Point of view

Redefining software engineering: The impact of generative AI
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Expert perspectives

Four of a kind: Capgemini’s partnership recognized with four AWS Partner of the Year 2024 Awards 

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Dec 3, 2024

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Dec 3, 2024

The critical need for data trust in business operations

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Nov 28, 2024

Meet our experts

Suresh-Sarojani

Suresh Sarojani

CTO MedTech, Capgemini Engineering