DESIGN ANALYSIS DATA Design Analysis Data for a medical device shall include the following:— (i) Physical and Metrological Standardisation. (ii) Design control documents and a predefined procedure of the medical device at the time of manufacturing. The Design Analysis should be carried out in accordance with the Standards as detailed in the Medical Devices Rules, 2017. A comprehensive report of design analysis including the basic design features of the device, drawings, and tests adapted for design analysis (with specifications) and rationale for selecting those tests and design control procedures shall be prepared.