4.0 Design and manufacturing information: 4.1 Device Design: The dossier should contain information to allow the reviewer to obtain a general understanding of the design stages applied to the device. The information may take in form of flow chart. Device design validation data should be submitted. 4.2 Manufacturing Processes: The dossier should contain information to allow the reviewer to obtain a general understanding of the manufacturing processes. The information may take the form of flow chart showing an overview of production, manufacturing environment, facilities and controls used for manufacturing, assembly, any final product testing, labelling and packaging and storage of the finished medical device. If the manufacturing process is carried out at multiple sites, the manufacturing activities at each site should be clearly specified.