Software as Medical Device
Large pharmaceutical companies present themselves more and more as broad healthcare companies rather than mere treatment providers. By offering tools that increase the understanding of an individual patient’s disease state and by linking this information to potential treatment responses, pharma companies are playing an active role in the creation of a fully personalized-medicine landscape. Since imaging is a cornerstone clinical diagnostic tool in different therapeutic areas, Radiomics can bring its expertise to the table in the creation of image-based precision medicine solutions also known as software as medical device (SAMD).
Radiomics has the potential to transfer research findings, originated from our clinical trial support services, into high quality and scalable software solutions. We use our expertise to guarantee accurate performance of these tools on images collected in daily clinical practice and assist our clients in obtaining the relevant regulatory approvals needed to make this software available for physicians.
Based on the AGILE philosophy, our software development methodology is focused on pinpointing the customer needs. Once an opportunity to transfer research findings into a software solution is identified, Radiomics’ development teams aim to build the Earliest Testable Product and improve it iteratively thanks to valuable user insights. This approach allows to speed up the development process and leads to build simpler and more efficient software solutions.
To ensure maximum reliability, our cloud-based infrastructure makes use of the latest containerization and auto-scaling technologies. Ensuring high availability while relying on tech top players security (e.g. Google).
We strive to follow best software engineering practices advised by international bodies such as IEC and IEEE. Our AGILE approach coupled with our quality management system, outlines an all-inclusive approach to encompass market and risk analysis, acceptance testing and system design considerations into planning stages. When developing solutions that require approval from regulatory bodies such as FDA or CE, we strive to ensure our solutions adhere if not surpass safety and design guidelines to deliver safe, effective and reliable tools.
Radiomics’ quality management system (QMS) for medical devices and services is ISO 13485 certified as of January 2022, following the audit of the notified body IMQ. More information can be found here.