Writing requirements that encode value Most product requirements documents are quietly dishonest. They claim to describe what a product must do, but in reality they describe what a product must not fail at. Accuracy thresholds, operating ranges, response times,...

Applying ISO 14971 to IVD devices A low-light tube luminometer is, on the surface, a straightforward instrument. A sample tube is placed in a dark enclosure, light emission is collected, converted to current by a photodiode, integrated over time, digitised, and...