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.
This control maps to 23 controls across 11 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 23 it maps to, and the evidence behind each claim, over MCP and REST.