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 devices and in vitro diagnostic medical devices. If the manufacturer does not carry out design and development activity, the same shall be recorded in the quality management system. The manufacturer shall maintain conformity with this Schedule to reflect the exclusions. 1.2 If any requirement in paragraph 7 (product realisation) of this Schedule is not applicable due to the nature of the medical device and in vitro diagnostic medical devices for which the quality management system is applied, the manufacturer does not need to include such a requirement in its quality management system.