2140 - Requirements Management Software

The construction and commissioning of the new National Healthcare Photonics Centre was completed in early 2019, with the development of an EN ISO 13485 certified quality management system in development. A process for requirements management must continue to be in place, and it is intended that a software solution procured to continue to cover this requirement. This ISO 13485 certification underpins the National Centre for Healthcare Photonics' business activity in progressing from the initial concept of a medical device, through developing a prototype, to putting together a complete manufacturing design, and pilot manufacture. Please see the Tender Pack in relation to CPI's detailed requirements.