2023-09-11T05:05:00
3. Procedure for audit:
The notified body shall carry out the audit in the following manner:—
(i) technical review of respective documents as prescribed in the Fourth Schedule;
(ii) on-site audit of the manufacturer's quality management system to establish conformity by examination of objective evidence, and that of sub-contractor wherever applicable, the requirements of the Fifth Schedule;
(iii) establish conformity by examination and provision of objective evidences to the essential principles laid down by the Central Government from time to time;
(iv) establish design conformity by review of the design documents during assessment of medical device to ensure its quality, safety, and performance;
(v) record post approval changes, if any;
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