We see 142k imprecise readings. Whose design V&V cut a corner?
@qmssarah78.bsky.social
@qmssarah78.bsky.socialWe see 142k imprecise readings. Whose design V&V cut a corner?
@qamia.bsky.socialy'all 90 minutes on one label format change last week. 8 minutes for the label. 82 minutes mapping downstream impact: DHF sections, supplier agreements, risk file, training docs. The change isn't the bottleneck. The impact analysis is. #MedicalDeviceQMS #ISO13485 #ChangeControl #CAPA #qmsWrapper
@botsocialista.ursal.zone.ap.brid.gyEsquerda: As lições da vitória em Berlim.
- bsoplvr
https://outraspalavras.net/movimentoserebeldias/esquerda-as-licoes-da-vitoria-em-berlim/
#MovimentoseRebeldias #Capa
@auditorpaige.bsky.socialCrumpet had his breakfast; I'm reading a mock audit where every CAPA action was 'retrain the operator'. A useful one comes from someone your team has never briefed. A mock auditor who knows your gaps guarantees the real one finds them. #MedicalDeviceQMS #ISO13485 #CAPA #AuditReady #qmsWrapper
@botsocialista.ursal.zone.ap.brid.gyAmérica Latina: a ultradireita tem projeto? .
- bsoplvr
https://outraspalavras.net/direita-assanhada/americalatina-ultradireita-tem-projeto/
#DireitaAssanhada #AmricaLatina #Capa #Classetrabalhadora #Crise #Criseeconmica #Direitaliberal #Economiamundial #Extremadireita #Gastospblicos #Globalismo […]
@botsocialista.ursal.zone.ap.brid.gySul Global: o desafio da reindustrialização.
- bsoplvr
https://outraspalavras.net/descolonizacoes/sul-global-o-desafio-da-reindustrializacao/
#Descolonizaes #AspectosdosDireitosdePropriedadeIntelectualRelacionadosaoComrcio #BancoCentral #BRICs #Capa #Fmi #Planejamentoestatal […]
@samqadani.bsky.social72k MAUDE reports wiht "no problem identified" isn't reassuring, that's post-market capturing noise instead of root causes.
api.fda.gov/device/event.json?search=date_recei…
@qmsnews.bsky.socialSix months into most eQMS implementations, the database wins. The event-driven, AI-routed vision from the demo becomes a structured folder hierarchy with search. Vendors sell transformation, IT delivers taxonomy. #eQMS #CAPA #MedDevice
@regafraid.bsky.socialEvery CAPA that reopens six months later had an effectiveness check signed off, never measured. QSIT reviewers cross-reference complaint trends against your own closure dates. A closed ticket is just a timestamp. #MedicalDeviceQMS #ISO13485 #CAPA #FDAInspection #AuditReady #qmsWrapper
@regaffairsyuki.bsky.socialUnder-rated part of qmsWrapper's AI: it's explicitly blocked from approving closure, reportability, risk acceptability, or submissions. The fence is the feature, not a gap.
qmswrapper.com/ai-qms-for-medical-devices
@ptsignificadode.bsky.socialSignificado de #capa 1º_ Uma capa de tecido usada sobre os ombros e costas, por cima da roupa. É uma redução da palavra capuz ou capuz. 2º_ Pelo primeiro, qualquer material que cubra outro, como uma camada de ferrugem ou uma camada de tinta. 3º_ Pelo primeiro, cada cama.. capa
@wordmeaningdic.bsky.socialMeaning of #capa 1º_ A cloth cover worn over the shoulders and back, on top of clothing. It is a reduction of the word hood or hood. 2º_ By the former, any material that covers another, such as a layer of rust, or a layer of paint. 3º_ By the former, each layer superimp.. capa
@significadode.bsky.socialSignificado de #capa 1º_ Cubierta de tela que se lleva sobre los hombros y la espalda, encima de la ropa. Es una reducción de la palabra capucha o caperuza. 2º_ Por el anterior, cualquier material que recubra a otro, como una capa de óxido, o una capa de pintura. 3º_ Po.. capa
@qmsnews.bsky.social
@leipzigerzeitung.bsky.socialKompromiss zum #Capa-Wäldchen am Cottaweg: Der BUND Leipzig schließt rechtliche Schritte nicht aus
@elmocrumley.bsky.social
@leipzigerzeitung.bsky.socialKompromiss-Vorschlag zum #Capa-Wäldchen: Kleinmesse vors Stadion, Wald nur beschneiden?
@regafraid.bsky.socialBD catheter tray recalled over contaminated wipes. Rough Monday for whoever onws supplier quality.
@samqadani.bsky.socialarthroTAK tendon anchor just cleared 510(k). Congrats. Now the unsexy clock starts, PMS plan refresh, risk file update, complaint routing.
accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pm…
@botsocialista.ursal.zone.ap.brid.gyA delicada questão do poder nas ecovilas.
- bsoplvr
https://outraspalavras.net/pos-capitalismo/a-delicada-questao-do-poder-nas-ecovilas/
#PsCapitalismo #Autenticidade #Capa #Coletivos #Comunidadeautnoma #Comunidades #Comunidadesalternativas #Comunidadesancestrais #Cultivo #Cultura […]