Medical device connectivity support
Our team can offer end-to-end support, whether you’re looking to bring connectivity to a device that’s yet to go to market, or need connectivity solutions to be implemented or improved on existing lab or point-of-care systems.
With developers, designers, product managers, and compliance officers in house, we can provide strategic or regulatory consultation, as well as solution planning, development, and delivery. We’ve worked with governments, charities, and health organisations across the globe to develop connectivity solutions that have helped save lives.
Our development team can also support you in testing or hosting your connected medical device solutions, and maintaining them long-term through ongoing product support, infrastructure, and cybersecurity services.
Providing effective connected health solutions
The Early Infant Diagnosis programme saw us work with Alere to improve workflow efficiencies through connected diagnostics, to lower infant mortality rates from HIV by reducing times to treatment. Existing methods used paper-based systems and had treatment times of up to 12 weeks in some countries, which would be too late for many.
We developed a platform that enabled diagnostic devices located at strategic hub clinics to connect and transmit patient results to a centralised data store. Data was then routed to SMS-enabled printers at remote locations. This provided a fast, accurate, and cost-effective means of aiding clinical decisions.
The connectivity solution had an enormous impact, taking time from testing to diagnosis down to just 3 days. Infants with HIV were moved promptly onto antiviral treatment programmes with great success.
Why choose us?
We’ve been working on global health projects since 2012 and have built up an impressive portfolio. The research, planning, and development that has gone into our work has given us a real understanding of the challenges facing countries and healthcare organisations, and has made our team passionate about connectivity in the MedTech sector.
01
Proven track record
We’ve been involved in global health for over a decade and have the knowledge required to implement connectivity solutions for a range of protocol, compliance, and performance needs.
02
Product validation
Your final solution must work as expected. With an accredited and experienced test team, we know how to qualify connected medical devices through efficient and thorough testing procedures.
03
Committed to quality
We work to the quality standards you need and expect. We are ISO-13485, ISO-14001, ISO-27001, and ISO-9001 accredited, and we implement these QMS for all projects, products, and solutions.
04
Support and implementation
Third-line support is available for every platform and solution we create so that you can get assistance whenever you need it. With our developers, testers, and cybersecurity experts, you can maintain your device’s connectivity with a life cycle approach.
How we can support you
Lab and point-of-care device connectivity can make the diagnostics and testing process more efficient and reliable, driving patients on to treatment and prevention programmes. We are dedicated to providing connectivity solutions that support these strategies. Some of the standards and protocols we work to include:
We develop connectivity solutions in line with Health Level Seven (HL7) standards in facilitating interoperability and data exchange across diverse medical platforms. HL7 protocols ensure smooth communication between healthcare applications, enhance data accuracy, streamline workflows, and improve patient care coordination.
We design connectivity solutions based on the ASTM message protocol, enabling efficient data exchange and interoperability across various medical systems. By leveraging ASTM standards, we ensure seamless communication between healthcare devices and applications, promote accurate data transmission, optimize operational workflows, and support enhanced coordination in patient care.
We specialise in connectivity solutions utilizing the POCT1A communication protocol, enabling efficient integration and data exchange between point-of-care medical devices and healthcare systems. By adhering to POCT1A standards, our solutions facilitate reliable communication, improve data accuracy, streamline device workflows, and enhance the coordination of patient care in diverse clinical settings.
Discover our TAC Portal – an end-to-end solution for the integration, management, and configuration of healthcare data across connected medical systems. Accredited in multiple ISO standards, including ISO 13485 and ISO 9001, as well as Cyber Essentials Plus, you can be confident that our TAC Portal will meet all your quality assurance and compliance requirements.
Clients we've partnered with
Who you'll be working with
Our standards and accreditations
SSDLC
We prioritise threat modelling, robust coding practices, and thorough medical software testing to fortify your product against vulnerabilities. With a commitment to compliance and continual improvement, our Secure Software Development Life Cycle (SSDLC) framework ensures a resilient software ecosystem, elevating your security standards and instilling confidence in your final product.
ISO 13485
Obtaining a level of connectivity is essential for ISO medical devices in order to transfer and receive clinical data, proactively manage device health, monitor inventory, and improve patient outcomes with more rapid diagnostic testing.
IEC 62304
We are well-versed in navigating the intricate requirements of IEC 62304 regulatory standards, ensuring the safety and efficacy of your software-based connected healthcare solutions. Whether our team is testing integration systems or building robust software solutions, you can rest assured that our cyber security protocols meet all IEC 62304 mandates.
OWASP Top 10
The Open Web Application Security Project’s (OWASP) Top 10 outlines the most prevalent web application vulnerabilities. Our healthcare cyber security strategies align with these key concerns, fortifying your applications against common threats.