Cloud strategy and IoT connections for your medical devices

Define your cloud strategy, make existing development activities leaner and extend the value you bring to customers with highly-integrated, compliant digital products and services. Our skills, tooling and industry experience will accelerate your time-to-market and ensure staying ahead of the strong competition.

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Challenges and opportunities

Embrace the software evolution

Medical device manufacturers face a rapidly evolving landscape, with software becoming vital to their strategies.

Stay competitive by closely monitoring medical software innovations and leveraging software's role in delivering business benefits and value.

Leverage digital transformation

MedTech's transformation into a reliable health data infrastructure presents new opportunities. As manufacturers evolve into SaaS businesses, they adopt new commercial models and focus on patient and caregiver-centric solutions. Seize the growth potential and enhanced patient experiences enabled by ongoing digital transformation, despite regulatory constraints.

Our guarantee

Our engineering operates in accordance with ISO 13485, ensuring the highest standards in medical software development for clients. Our commitment to EU Medical Device Regulation and US FDA Medical Device Regulation compliance guarantees we navigate the complexities of the MedTech landscape, helping clients adapt and thrive in this evolving industry.

How we can help

Device connectivity

By employing on-prem and/or cloud technology we help MedTech leap into the Internet of Medical Things (IoMT). We have extensive experience delivering highly usable and performant systems, while respecting privacy and security concerns.

Digital twins

Virtual models of medical devices allow for improved diagnosis, treatment planning, device monitoring, and optimisation. This can result in better patient outcomes, easier staff training, reduced costs, and increased efficiency in healthcare.

Interoperability with healthcare

We have extensive experience with IEEE 11073, IHE, HL7 FHIR, HL7 v2, SDPi, OpenEHR and other interoperability standards and approaches; be it in hospitals, community healthcare providers, or (inter)national initiatives. Thus, we can help you achieve good alignment with any of those environments.

Research and data

The goal is to prepare trustworthy, safe, and high-quality data, create combined datasets of medical device and clinical data, and support data holders and their secondary use scenarios.

Regulations and standards

ISO 13485

Outlines the requirements for the quality management system of medical device manufacturers to ensure they meet regulatory requirements and consistently provide safe and effective products.

IEC 62304

Specifies life-cycle requirements for development of medical software and software within medical devices. Harmonised by the EU and the US, it can be used to comply with both of these markets.

ISO 14971

Specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.

IEC 62366

Specifies the process for usability engineering in the development and evaluation of medical devices, ensuring their safe and effective use by end-users.


The European Union Medical Device Regulation (EU MDR) governs the safety and performance of medical devices within the EU market. It ensures that medical devices meet high-quality standards and mandates CE Marking, which signifies a device's compliance with EU health, safety, and environmental requirements.


The United States Food and Drug Administration (FDA) Medical Device Regulation sets the standards for safety, effectiveness, and quality of medical devices distributed in the US. It involves a stringent approval process, ensuring that devices are fit for their intended use and minimising potential risks to patients.

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Who we are

As engineers and consultants, we develop world-class digital products in highly regulated industries and help our customers capture the value of IoT.

Partnering with organisations looking to leap-frog in the area of cloud and digital innovation, our approach utilises bleeding-edge technologies, DevSecOps methodology, and our own CI/CD pipeline and home-brewed tools to deliver efficiency. 

With our extensive experience and specific domain knowledge, coupled with a product development mindset, we are the perfect partner for your digital transformation.

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Let’s change healthcare for the better, together.

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