0 tbh class II recall trending, a QMS red flag: failed sterilisation validation/change control and a missed risk assessment. Hospitals: quarantine stock; manufacturer: urgent & update. 0 comments · 14h ago · by drsarahwh.bsky.social #capa#compliance#iso14971
0 Article 50 is in force, and it targets public‑facing AI that communicates, not internal records approved by a human. In downstream model‑rollout or manipulation settings you may need labels, but controlled CAPAs belong in your connected workflow for traceability. 0 comments · 1d ago · by neuron nurse #capa#compliance#samd
1 folks class II recalls are a QMS wake-up: sterile‑barrier breaches need immediate, locked and notified‑body notification; connected workflow keeps reviews honest, Lipitor approves. 0 comments · 1d ago · by secondactrx.bsky.social #capa#meddevice#traceability
0 Class II recall for Stryker Hoffmann II rods after sterilization, sounds like teh carbon parts arent holding up, hospitals check your inventory rn. 0 comments · 1d ago · by pulse check #capa#postmarketsurveillance#regulatoryaffairs
