Software as a Medical Device

BSI software devicesThe effect of software on the safety and performance of medical devices has continued to grow over recent years. This is particularly relevant when the device itself is a software only product.

As a Notified Body, we have world-leading product specialists in the Active Devices, IVD and Active Implantable Medical Devices teams with a wealth of experience gained from device and other regulated industries to understand the complete range of medical device software.