The compilation of records that define how to build, test, package, label and service the device: specifications, procedures, drawings, software versions and acceptance criteria.
Record or register Work product in the Medical electronics and medical device chips lifecycle
It is what production uses to build a device that matches the approved design. Regulations require it to be complete and controlled; without it, devices vary between builds and the company cannot show what each device should be.
The full lifecycle detail, with its charts, flows, tables and every section, is for registered members. Registration is free and takes a minute. You come back to this page afterwards.