Intelligent MEDICAL PRODUCTS and systems

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
• Ensuring reliable and secure integration and interoperability in the connected health ecosystem
• 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 extensive regulatory knowledge, certified processes and assets.

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 complex assemblies, optimizing them, integrating sensors and wearables or engineering complete end-to-end connected medical systems, processing signals, data, images and generating new AI enabled diagnostics or digital biomarkers, 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.

Intelligent Medical Products and Systems (IMPS) framework

Our Intelligent Medical Products and Systems (IMPS) framework provides an ideal foundation for Pharma and MedTech companies to build or extend their connected health solutions. It incorporates a set of tools, processes and libraries to significantly accelerate the development of compliant, GxP and SAMD-ready connected health systems. A composable solution with a microservices-based architecture using modular software building blocks, the framework provides curated reusable components, APIs and use-case specific blueprints to efficiently realize fully customizable and scalable digital health products and platform-based solutions.

Focused on interoperability, connectivity and data management, our IMPS framework is developed under certified processes and cybersecurity by design, supporting up to Class III SAMD. As a cloud-agnostic solution (AWS, Azure, Google Cloud compatible) with built-in healthcare interoperability (HL7/ FHIR/ DICOM, etc.), it enables ease of connectivity into the health ecosystem as well as integration with 3rd party systems.  It provides unprecedented flexibility and the ability to maintain full control of your IP, and to manage the evolution of your connected health system.

We can also ease compliance burden with full regulatory support throughout the lifecycle as well as take full responsibility as Legal Manufacturer of SAMD

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.