AI drafted the impact list. I still own the audit answer.
The change that looked small Last month, a change request landed on my queue for a heat-treat subcontractor who had moved two of their furnace zones to a different EMS provider. Twelve components in scope. Four device families downstream. The change form asked one question at the top: which DHF documents does this touch? For a Class IIa implant component, that question is not a checkbox. Get it…
A recent change request resulted in a small modification for a heat-treat subcontractor who moved two furnace zones to a new EMS provider. This change touched twelve components and four downstream device families. However, the AI impact analysis missed three crucial factors: shared sterilization load configurations, a previously changed cleaning process, and a CAPA tied to the furnace's temperature uniformity map.
ISO 13485:2016 requires human review and approval of changes, with a clear audit trail showing who reviewed and approved the impact analysis. AI can assist in surfacing potential impacts, but the final decision and responsible documentation must be handled by a human. A compliant process involves reviewing and approving each AI-suggested change, with a reviewer's per-item justification retained for the audit trail.
Written by urgent.news from Dev.to's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
