Medtech itself is at an unprecedented turning point, pivoting away from traditional healthcare service providers to the patient/user themselves. This transition can be seen across diagnosis and delivery - often relying on software-oriented devices and products to provide the solutions. However, the ability of regulatory bodies to establish a framework that encompasses everything from traditional product designs, modern technology capabilities, algorithmic processing such as AI/ML and remote use from non-medical professionals is a significant challenge. The sheer breadth of technological application to the marketplace has now shifted the goalposts to a place where prior established frameworks need constant revisiting. In this talk, I will describe how software (particularly AI/ML based) products fit into this framework, how developers can navigate the challenges around regulatory submission, and how AND Technology can help.