As technology progresses, the digital solutions we use in healthcare become not only more insightful, but also more complicated. Medical Devices are often thought of as bits of hardware such as pacemakers, insulin pumps, or scalpels; however, due to the increased complexity and function of cutting edge healthcare software, more of it is qualifying as Software as a Medical Device (SaMD) which falls under Medical Devices Regulations (MDRs).
When a device has a medical function (such as diagnosis, prevention, monitoring or alleviation of disease), it becomes subject to MDRs to ensure they are robustly manufactured and monitored throughout their lifecycle to deliver the safest healthcare to patients. We now find many software applications have an intended purpose which qualifies them as a Medical Device, making them also subject to the same regulations to ensure patient safety.
NCISS have a suite of perpetually learning experts alongside an experienced and dedicated Quality Team who can help you to make informed decisions about your digital solution throughout its lifecycle, as well as support you in any future pathways. Our Quality Team has extensive real-life experience with medical devices, and NCISS are currently integral in maintaining NSS-owned medical devices within our Quality Management System.
NCISS can help you with:
- determining if your digital solution is likely to qualify as SaMD, through one of our MDR Clinics
- This could be due to a new change to functionality in the solution or something inherent in the design of a new system
- advice on the likely classification/categorisation of your digital solution
- regulatory compliance advice on SaMD and AI as a Medical Device (AIaMD)
- advice on any next steps, including the process of making your solution compliant