User Stories: Mind issues with regulatory compliance
Medical device manufacturers, in particular software developers, frequently employ user stories to derive respectively to document requirements. Manufacturers should keep regulatory requirements in mind when doing so. Learn more about the traps with user stories.
Main Operating Functions
The IEC 62366 formulates requirements for the main operating functions of medical devices. Unfortunately, they do not define the term function and causes confusion. This article provides a definition and examples of medical products main operating functions more..
The ISO 9241 is an entire family of standards originally from the "Ergonomic requirements for office work with visual display units”. Meanwhile, the applicability of ISO 9241 has further developed to every form of products more..