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Version devBuilt at: 2026-10-11 02:37:10 EDT

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@pryormarking.bsky.socialSep 7, 2026, 10:00 AM

See the full spec: machines.pryormarkin...

#LaserMarking #PartMarking #Manufacturing #MadeInSheffield #Traceability

@qmsnews.bsky.socialSep 7, 2026, 8:22 AM

The EU AI Act makes AI medical-device changes a traceability test: risk controls, validation evidence, and technical documentation must stay connected.

#EUAIAct #MedicalDeviceQMS #Traceability #ChangeControl
https://eur-lex.europa.eu/eli/reg/2024/1689/oj

@regafraid.bsky.socialSep 6, 2026, 8:37 AM

Avoid mutiny: convert binder sections into qmsWrapper 10.2 Technical Files - auto-scored, AI impact maps and traceable links reassure reviewers.

#Traceability #ISO13485 #TechnicalFile

@regaffairsyuki.bsky.socialSep 6, 2026, 12:28 AM

Audit trails must live in the platform, Excel backups mask magnitude & bias.

#Traceability #DataIntegrity #ISO13485

@regafraid.bsky.socialSep 3, 2026, 1:51 PM

171,928 failed osseointegrations, heartbreaking; hope clinicians, patients and regulators get clear answers fast.

#CAPA #ISO13485 #Traceability

medical device failure
@samqadani.bsky.socialSep 3, 2026, 10:58 AM

107k "low readings" MAUDE hits, probably a logging/duplicate storm, but don't assume: triage + dedupe, map to device risk, open automated CAPAs for validated clusters; insist on.

#QualityManagement #Traceability #CAPA

@pryormarking.bsky.socialSep 3, 2026, 8:20 AM

Get in touch to arrange a meeting at either expo or book a visit to your site www.pryormarking.com...

#LaserMarking #DotPeen #MadeInSheffield #Traceability #BritishManufacturing #ManufacturingUK