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Quality and certifications

Secure and certified solutions for a global market

Paramedic ePR Ambulance UK

Highest standards of quality and safety

Our commitment to quality and safety runs deep. We are certified to ISO 13485, ISO 27001, ISO 20000-1 and Cyber Essentials (UK), and our products are CE-marked as Class IIb medical devices under the MDR. This ensures our solutions are not only innovative but also safe, reliable, and compliant with regulatory requirements.

Globally approved solutions

Our global reach and capability to deliver secure solutions extend far beyond the EU. Our products meet the requirements for the UK market under the MHRA and are included in the Australian Register of Therapeutic Goods (ARTG) via the TGA, confirming their approval for supply in Australia.

We are also proud to be listed on the G-Cloud 14 framework, administered by the UK Government Commercial Agency (GCA), through which we provide our MobiMed solution to ambulance services.

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Certificates

We are certified by Intertek according to ISO 13485, ISO 27001, and ISO 20000-1. These certifications demonstrate to our customers, partners, and suppliers that we priorities continuous improvements in order to deliver products and services of the highest quality.

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Environmentally conscious manufacturing

Our goal is to minimise the use of hazardous substances in both the production and delivery of our products. Every aspect of our operations, from packaging and accessories to repairs, is carefully evaluated to reduce environmental impact. While our proprietary hardware is produced by trusted subcontractors, we set strict specifications and ensure that environmental management is a key factor in selecting our partners. Together with our subcontractors, we choose materials, components, and production methods that align with our sustainability goals. All our products fully comply with the RoHS Directive, limiting the use of hazardous substances in electrical and electronic equipment.

Trusted by

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MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK authority responsible for overseeing the safety, quality, and performance of medical devices. Our products meet the necessary requirements for placement on the UK market.

TGA and ARTG

The Therapeutic Goods Administration (TGA) regulates therapeutic goods, including medical devices, in Australia. Products approved for supply are listed in the Australian Register of Therapeutic Goods (ARTG), which is maintained by the TGA. Our products are included in the ARTG, confirming that they meet the requirements for supply in Australia.

CCS and G-Cloud 14

We are proud to be listed on the G-Cloud 14 framework, administered by the UK Government’s Crown Commercial Service (CCS). Through this framework, we supply ambulance services with our MobiMed solution, supporting pre-hospital care with reliable digital solutions.

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