A growing medical technology organisation with innovative lung imaging capability delivering reporting via a Software as a Service solution, needs to maintain compliance with NIST, ISO27001 and HIPAA.
4DMedical is a global medical technology company aiming to change the outcome for patients with lung disease by revolutionising respiratory imaging and ventilation analysis. Their SaaS based solution allows for medical imaging data to be transferred to 4DMedical for processing and reporting.
While navigating Food and Drug Administration (FDA) approval processes in the United States, 4DMedical needed to consider the cybersecurity requirements of their product in order to satisfy the FDA, ensure appropriate risk and reputation management and to inform the market as they seek a technology platform provider.
Information Professionals Group developed a Cybersecurity Reference Architecture, product security requirements, and cyber solutions architecture in addition to providing inputs into the successful FDA submission around cybersecurity.
Specifically, the Cybersecurity Architecture needed to consider:
We’ve continued to work with 4DMedical by performing Threat and Risk assessments on their service delivery solution, solution development and corporate functions.
Our most recent project has been working with the 4DMedical team to establish ISO27000 Cyber Governance via an Information Security Management System (ISMS), which is being integrated with the organisations QMS.
The developed solution was compliant with both the needs of the client and the regulator, with a full FDA approval being achieved. This approval allowed for the launch of the first element of 4DMedical’s technology, which will revolutionise the diagnosis and treatment of lung disease across the globe.
Thanks to the collaborative approach between Information Professionals Group and 4DMedical’s internal team, the client has been able to realise a significant uplift in their technical and business capability.