The controlled list of standards, regulations and guidance documents that the medical device and its chips must meet, with the edition, the parts that apply and how conformity will be shown.
Record or register Work product in the Medical electronics and medical device chips lifecycle
It fixes, early in design, which rules the device will be judged against. Test plans that miss required standards or use superseded editions invite a challenge to the submission when conformity to a standard the regulator expects was never planned.
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.