Design and development verification: Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained.

FIFTH SCHEDULE [Refer rules 20(3), 20(5), 20(8), 22(i)] QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES 1. General Requirements: 1.1 This Schedule specifies requirements for a quality management system that shall be used by the manufacturer for the design and development, manufacture, packaging, labelling, testing, installation and servicing of medical device ...