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Solution

Intelligent medical products and systems

Unlock the value of connected health

Accelerate the development of safe, reliable, and intelligent medical solutions

Intelligent medical products and systems are opening the door to a new era of healthcare, connecting patients, doctors, devices and entire healthcare systems. They offer increased agency, mobility, and ultimately – better outcomes.

Today’s technology and data enable:

  • faster, more accurate diagnostics
  • more efficient and effective treatments
  • more convenient and less costly patient care

Intelligent medical products and systems make healthcare resources available at home and at doctors’ offices, reserving hospital care for extreme needs only. They improve care and safety through remote and integrated monitoring. And they deliver better outcomes through personalized medicine and improved patient experience.

See for yourself

The echo-stethoscope of the 21st century.

Intelligent medical products & systems are accelerating the convergence of Connected Health technologies and medical devices as part of a holistic, end-to-end digital healthcare ecosystem. However, this transformation brings with it increased complexity across development, operations, regulatory, and post market support.

The potential is enormous, but the challenges are also significant:

  • Time to market and cost pressures in an increasingly competitive environment
  • Breaking down functional and technological silos for efficient and integrated care
  • Securing the data critical for patient insights, safety and well-being
  • Managing regulatory compliance when technology evolves at multiple times the speed of regulation
  • Global scaling and sustenance across markets with different local requirements

Succeeding in the complex connected health ecosystem requires deep multidisciplinary expertise combined with and extensive regulatory knowledge.

We are a recognized global leader in medical devices, connected medical devices, MedTech digital transformation and patient engagement services. With over 35 years of experience in over 30 clinical categories, our medical device expertise includes:

Our full-lifecycle services accelerate the build, launch and operation at scale of intelligent medical products & systems, supported by strong regulatory, quality & compliance capabilities.

From components to complete connected systems

Whether you’re developing mechanical assemblies, optimizing them, or engineering complete end-to-end connected medical systems, we’re here to accompany you on your entire journey. From biocompatible enclosures and electro-mechanical components, power and electronics, embedded software, mobile and web apps, sensors and IoT devices to cloud platforms and distributed systems, integrated and interoperable with new or legacy health IT, we deliver.

Complete lifecycle support

We support R&D from business concept and product strategy through design, development, verification and validation, and product certification. Beyond the engineering lifecycle we also support the business and regulatory strategy and the consequent operational launch, regulatory approval, and lifecycle maintenance including post-market surveillance and quality management support.

Finding value in intelligent medical products

Unlock the value of connected health

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Our offers

We design secure, compliant, and engaging omni-channel digital health solutions (and platforms) that integrate seamlessly into the healthcare ecosystem. Our built-to-grow approach leverages our strong domain expertise coupled with deep regulatory knowledge. 

We combine user insights, new technologies, regulatory rigor, advanced systems engineering, and breakthrough business models to improve health outcomes, create business value, and delight users. E2E medical devices empower healthcare innovators to create, develop, and launch regulated smart products and services.

From developing the strategy, through audits and deployment, to validation and operations, we help our clients ensure end-to-end privacy and security of data.

Software-driven transformation across regulated platform & product engineering, engineering & lifecycle processes & transformative business models.
 
With our global network of experts and more than 25 dedicated labs, we support the development, testing, certification and sustenance of a wide variety of medical products and systems. Our dedicated toolchains and proprietary frameworks accelerate product development, including:

  • Simulations;
  • our hardward in-the loop and automated test suite;
  • our DevSecOps pipeline.

We provide best-in-class consulting and managed services combining deep sector know-how, extensive regulatory & compliance expertise – including approaches for rapid deployment – leveraging data & digital technologies to improve performance, quality and regulatory compliance. ​

We support clients with regulatory strategy, regulatory documentation, audits, gap analyses and remediation activities and QMS optimization, managed services and operational QA/RA support at scale.

Certifications and compliance

We are certified to ISO 13485, ISO 27001, ISO 9001, ISO 14001, CMMIDEV/5 CMMISVC/5 and compliant to MRD, IVDR, 21 CFR 820, GDPR, HIPAA, and GxP.

What’s next

Your medical products and system innovations have the potential to bring value to people’s lives. Let’s take them to market – quickly and safely. Contact one of our experts and find out how our capabilities can enhance your R&D.

Meet our experts

Abhishek Khandelwal

Vice President, Engineering and R&D Services, Capgemini Engineering

Atul Kurani

Vice President, Head of Medical and IoT business, Capgemini Engineering