The record of each market authorisation obtained for the device, such as clearances, approvals or certificates, with the scope, conditions, dates and obligations attached.
Certificate or sign-off Work product in the Medical electronics and medical device chips lifecycle
It defines exactly what the company may sell, where and with what claims. Devices shipped to markets or with claims not covered, missed conditions of approval and lapsed renewals can each stop sales.
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.