Design input beyond requirements Using value drivers to shape real design decisions When organisations look to develop a product—internally or with external assistance—the instinct is often to start by writing a comprehensive requirements specification. This document...
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...