Twenty-four million dollars to former executives. Corporate governance in medtech: lavishly generous on the way out, austere on the way in.
@regafraid.bsky.social
@regafraid.bsky.socialTwenty-four million dollars to former executives. Corporate governance in medtech: lavishly generous on the way out, austere on the way in.
@cdjplus.bsky.socialRobert (Bob) Kennedy writes in our latest Reflection on quality management approaches in community development work, and how concepts of Quality, Excellence and Systems can be tailored to CD applications for improved outcomes buff.ly/MCZj7dl #CDJ #QualityManagement
@solinear-ltd.bsky.social
@auditorpaige.bsky.socialQMS rollouts die from sprawl. Templates multiply, cross-links rot, traceability drifts by month six. Cleanest step-by-step for ISO 13485 teams I've seen: #ISO13485 #MedicalDeviceQMS #QualityManagement #AuditReady #QMSImplementation #qmsWrapper
youtube.com/watch?v=-Cgiq4vvNro
@bianorbiotech.bsky.socialAlgunos consejos para las clínicas en la era de las roturas de la cadena de suministros. Prevenir y mantener la calidad.
buff.ly/UUsGMnR
#binanorbiotech #SupplyChain #QualityManagement #Clinic
@newsramp.comGlobal Manager Group has launched its ISO 9001:2026 Documents Kit — 188+ editable templates including procedures, SOPs, audit checklists, and flowcharts to streamline QMS implementation and certification prep. A free demo is available for review. #ISO9001 #QualityManagement
@newsramp.comPunyam Academy has launched a new self-paced ISO 9001:2026 QMS Lead Auditor Training course featuring 400+ audit questions, real-life demonstrations, and a completion certificate. Now available for quality professionals worldwide. #ISO9001 #QualityManagement
@regafraid.bsky.socialAnnex 11 §14 is a control requirement, not a technology requirement. NB auditors I've worked with apply the same hierarchy: integrity of the record beats integrity of the signature.
@elliginthealth.comWe’re excited to announce a new strategic partnership between Elligint Health and Laguna Health, bringing conversational AI capabilities into the care management ecosystem our clients rely on.
Read the full pr: bit.ly/4jH2tyH
#QualityManagement #NCQA #ArtificialIntelligence #HealthcareInnovation
@auditorpaige.bsky.socialClass I recall from a Sodium Chloride supplier, propagating through every kit containing that ampule. If your QMS can't trace that cascade in one connected workflow, the FDA letter finds it first.
api.fda.gov/device/enforcement.json?search=reca…
@regaffairsyuki.bsky.socialThe Aisys CS2 auto-O2-switch recall is why post-market signal must flow back into the design history file, not sit in a siloed complaint log.
@regafraid.bsky.socialAisys CS2 Et Control in a Class II recall means the failure mode sits somewhere the design FMEA didn't exercise. Trace it back, that's where the belongs.
@qmssarah78.bsky.socialgap you find yourself is a fix. Gap the auditor finds is a finding. Any tool that surfaces audit-risk holes before the visit earns its keep, pretty checklists aren't enough.
@intlaccredservc.bsky.socialPreparing for ISO/IEC 17020? Focus on the basics: qualified staff, impartiality, solid methods, and traceable records.
Prove your agency's competence.
🔗https://t.co/ngu3XnDJer
#AccreditationReady #ISO17020 #InspectionBody #QualityManagement #IASAccreditation
@elgarpublishing.bsky.social🚨OUT NOW
Quality 4.0 and #ArtificialIntelligence
Technologies, Metrics and Practice for the Inclusive and Smart Factory
dr JOANNA ROSAK-SZYROCKA and Radosław Wolniak
Read the intro doi.org/10.4337/9781...
ℹ️ tinyurl.com/yc2mvzc4
#AI #QualityManagement #Digitalisation #Sustainability #ESG
@qmsnews.bsky.socialDatex-Ohmeda's Aisys CS2 just got pulled for a firmware fault that silently flips the device into backup O2 control. The kind of failure mode that hinges on whether risk files and CAPAs actually connect.
api.fda.gov/device/enforcement.json?search=reca…
@regafraid.bsky.socialHalyard's Class I started as Spectra's ampule recall. Supplier NCs siloed from finished-device risk files are post-market surprises in the making.
@qamia.bsky.social30 min slides, 25 min "but here's why OUR gap-analysis template is better." Actual learning: the 5 min Q&A. ASQ chapters and notified body workshops beat vendor pitch decks every time. Anyone else ditching these? 🫠📋 #ISO13485 #MedTech #QualityManagement #RegulatoryAffairs #CAPA #qmsWrapper
@interimcoo.bsky.social80% of serious outages are preventable process failures, not hardware faults or simple operator error. Fix the written procedure to prevent the next incident: https://smbadvisor.management/root-cause-analysis/ #QualityManagement #ProcessImprovement #DevOps #SRE
@regafraid.bsky.socialXtreem Pulse has their 510(k). Now the quality system matters, how fast can post-market signals feed back into design changes and risk files? That's the real regulatory clock.