Capgemini as your legal manufacturer for SaMD

Increase efficiency, reduce regulatory complexity for your sofware-as-a-medical device (SaMD)

Regulatory authorities recognize that digital health solutions are increasingly connected and multi-functional. Some of these solutions are regulated, as Software as a Medical Device (SaMD) and require authorities’ approval before market placement. We have extensive experience building intelligent, connected devices. As a legal manufacturer, we’re also certified to take you across the finish line and assume full regulatory responsibility. ​​

By choosing Capgemini , you not only reduce your risk, but you also gain multiple efficiencies, as compliance is built into the connected medical device lifecycle from the start. In the era of connected health solutions, an end-to-end digital partner plays a crucial role. From inception through launch, we help speed up your time to market and reduce the complexity of your solution once on the market.

Liability in the era of connected healthcare​

From data sharing to patient monitoring, connected health services are changing the landscape. ​​

Hospitals manage administrative functions, billing management, and patient record storage. MedTech companies leverage analytics, real world data, image processing, and diagnostic recommendations. Patients and healthcare professionals use mobile applications for communication, appointment management, data sharing, education, remote patient monitoring, sensor data interpretation, medication adherence support, and diagnostic or therapeutic recommendations. All of these functions are subject to various regulations, which includes data privacy and medical devices regulation.​​

An experienced legal manufacturer takes this off your hands. Our ISO 13485 certified Quality Management System ensures adherence to regulatory standards, and we actively engage with health authorities and notified bodies for regulatory strategy, technical file development, registration, post-market surveillance, and support.​

Decrease your time to market ​

We offer comprehensive end-to-end services that encompass entire product life cycles as well as collateral services. Our system-based approach builds compliance into every step, helping your digital medical devices reach the market faster, and dramatically reducing risk.​​

Faster and safer with a modular framework ​

A pragmatic approach to accelerate SaMD development while managing regulatory complexity and maintaining flexibility and safety, is to apply a systems approach, modularize and segregate SaMD products by function and by risk category (high, medium and low risk). This makes it possible to apply the appropriate level of risk control and testing measures in each case. Using pre-built, ready-to-use SaMD modules developed under certified processes and with qualified tools, assures reliable, fast and compliant software. Compared to a traditional, ground-up approach you gain greater efficiency and impeccable safety by applying our Intelligent Medical Products and Systems (IMPS) framework.​​

Experience counts ​

We’ve worked in the life sciences field for decades, in the software field for even longer, and we bring further capabilities from across our Group industries. We’ve supported many of the leading pharmaceutical and MedTech companies with their intelligent  medical products and systems, and our modular approach is built out of the experience we’ve gained in those years. ​​

We’re with you for the long run. We’re with you to help ensure your products’ safety, compliance and long-term success. ​