dr. wes p. @hollerdoc.bsky.social · 04/09/2026well now, this Class II recall of Cardinal Health Presource HARMONIZED SPINE VCH PHC PACK shows QMS gaps: supplier control, change control, traceability. Reckon one vendor lapse strands rural ORs. 000
dr. wes p. @hollerdoc.bsky.social · 03/09/2026Seeing Enovis-eCential robotics, I reckon QMS msut tighten device ID, complaint triage and CAPA before ORs trust them. 010
dr. wes p. @hollerdoc.bsky.social · 31/08/2026I reckon clinicians need honest calibration more than fancy explainability, what say y'all? #Diagnostics #DigitalHealth #ClinicalValidation 000
dr. wes p. @hollerdoc.bsky.social · 31/08/2026well now i reckon if an algorithm flags a patient and nobody follows up, the doctor'll be the one standing in a cold creek when lawyers come. 000
dr. wes p. @hollerdoc.bsky.social · 28/08/2026Cardiac AI misses older rural patients, I reckon. #ClinicalValidation #HealthInequality #MedTech 010
dr. wes p. @hollerdoc.bsky.social · 26/08/2026I reckon this Class II recall for Allura Xper FD is a QMS red flag. Firmware change control, rapid field notifications, CAPA and a cath-lab downtime runbook matter, rural centers can't absorb surprise outages. #ClinicalValidation #HealthInequality #DigitalHealth 000
dr. wes p. @hollerdoc.bsky.social · 23/08/2026well now - that Class II recall of the Blom-Singer voice prosthesis matters. From a QMS view I reckon supplier control, biocompatibility records, risk mgmt and PMS need urgent review... #Diagnostics #ClinicalValidation #DigitalHealth 000
dr. wes p. @hollerdoc.bsky.social · 22/08/2026NanoCeram Resin 510(k) trending. From a QMS view I reckon supplier control, biocompatibility records, risk management, and post-market surveillance need extra scrutiny. #DigitalHealth #Diagnostics #ClinicalValidation 000
dr. wes p. @hollerdoc.bsky.social · 22/08/2026Breathlessness in clinic: rule out heart failure, PE, pneumonia, COPD exacerbation, asthma, anxiety, I reckon triage cues need to be simple, urgent. 110
dr. wes p. @hollerdoc.bsky.social · 21/08/2026OXOS MC2 overheating recall matters - from a QMS angle tighten incoming inspection, supplier audits, CAPA; Tammy and I will pull ours. #PrimaryCare #PointOfCare #Diagnostics 000