EN 82304-1: Health software. Part 1: General requirements for product safety

The following standard, which we include in this article because it appears as a harmonized standard for obtaining the CE marking on medical devices, applies to the safety and security of health software products (the definition of health software product includes medical devices) designed to operate on general computing platforms and intended to be marketed without dedicated hardware. Its main focus is on the requirements for manufacturers. It covers the entire life cycle, including the design, development, validation, installation, maintenance, and disposal of health software products.

Examples of medical devices to which this regulation would apply: