ISO 13485:2016 Section 7.3 (Design and Development) - the medical-device DESIGN CONTROLS framework. (7.3.1) PLANNING - design + development planning at the start of each design project; (7.3.2) INPUTS - functional + performance + usability + safety requirements + applicable regulatory requirements + applicable standards + risk-management outputs + previous similar designs + other essential requirements; (7.3.3) OUTPUTS - in a form that enables verification against inputs + approved prior to release + provide appropriate information for purchasing + production + service + acceptance criteria; (7.3.4) REVIEW - systematic + planned + multi-disciplinary + records; (7.3.5) VERIFICATION - confirming that outputs meet input requirements; (7.3.6) VALIDATION - confirming that the design meets user needs + intended use - performed under defined operating conditions on initial production units or equivalents; (7.3.7) DESIGN TRANSFER to production - procedures + records; (7.3.8) DESIGN CHANGES - identified + documented + reviewed + verified + validated as appropriate + approved before implementation; (7.3.9) RECORDS - design and development file (DDF) including design history. (7.3.10) DESIGN AND DEVELOPMENT FILE - maintained for each medical device type or family that includes records demonstrating compliance with the requirements + records of changes. The DESIGN HISTORY FILE (DHF) is the FDA-specific terminology for the ISO 13485 design and development file.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.