// AI news · 2026-10-31 · Dev.to AI
A defensible DHF is an evidence chain, not a document shelf
A defensible design history file is an evidence chain, not a collection of static documents.
Published 2026-10-31 01:36 (Beijing time)Source Dev.to AIAuto-summarised, fact-checked against source
01Summary
It must trace decisions from input through risk assessment to implementation and release, enabling bidirectional audit trails. Each change requires explicit hazard analysis and documented rationale under ISO 14971:2019. Superseded versions, review comments, and change reasons must be preserved for full traceability.
Summarised from the original article by an open-source model, then checked automatically: every number and English name must appear in the source. The original article is authoritative.
02Key points
- Start with quality events, not document collection.
- Evidence chain must be bidirectional and logically connected.
- Risk reviews must analyze hazard changes, not just state 'no impact'.
- All revisions, comments, and change reasons must be preserved.
03Source
A defensible DHF is a connected evidence trail, not a shelf of final documents
Dev.to AI · published 2026-10-31 01:36 Beijing time
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