Least Burdensome

Least Burdensome is the FDA principle of the least required effort: generate no more effort and evidence than controlling the identified risk demands. It explicitly does not mean testing or documenting as little as possible – high risk still requires…

Lifecycle

The lifecycle describes the entire lifespan of a computerized system or AI model: concept, specification, verification and validation, operation, and decommissioning. Each specification step has its corresponding verification – classically in the V-model, and equally in agile and iterative models.…