A centralized hazard log only reduces audit friction if the scoring behind it has the resolution to actually drive design decisions. Otherwise you've just relocated the weakness to one tidy place.
@regafraid.bsky.social
@regafraid.bsky.socialA centralized hazard log only reduces audit friction if the scoring behind it has the resolution to actually drive design decisions. Otherwise you've just relocated the weakness to one tidy place.
@qmsnews.bsky.socialTired of QMS docs and project tasks drifting out of sync? This demo shows a setup where QMS processes actually drive the project work. #qmsWrapper #DesignControl #Traceability #ISO13485 #MedicalDeviceQMS
youtube.com/watch?v=7jV_KUs155E
@qamia.bsky.socialNew multiplex respiratory paenl clearing FDA, genuinely good for patients and clinics. Also: someone just updated a DHF, risk file, and IFU under serious time pressure. I hope their QMS is actually connected. 📋
accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pm…
@qamia.bsky.socialMy PCP still takes 3 days to tell me flu vs RSV. So yeah, faster respiratory panels clearing FDA = less me spiraling in a waiting room wondering if I need antibiotics. Welcome news 🫠
@qamia.bsky.socialjust flinchde reading about new spine devices.
@qmsnews.bsky.socialMidmark's IQvitals Zone just hit Class II for blood pressure inaccuracy: the kind of recall that usually traces to a design-verification gap or calibration-drift control fail. Worth stress-testing your own CAPA inputs.
@qmsnews.bsky.socialISO 13485 traceability breaks audits when design inputs, V&V, and risk controls live in separate Excel tabs. A walkthrough maps the matrix without the sprawl.
#ISO13485 #Traceability #MedicalDeviceQMS #DesignControl #AuditReady #qmsWrapper
youtube.com/watch?v=DmsB1NgiRYo
@regafraid.bsky.socialClass III PMA approval and a Class II recall trending in the same week. Companies obsess over the DHF. The QMS that handles the post-market grind is what determines whether you stay on market.
@qmssarah78.bsky.socialREADI-Home's decentralised data will test your design-to-PMS links, if they're not there now, home users will find the gaps before FDA does.
@auditorpaige.bsky.socialFolder structure is where eQMS rollouts quietly die. Traceability by linkage, not by directory depth. Worth a look: #MedicalDeviceQMS #ISO13485 #CAPA #DesignControl #Traceability #qmsWrapper...
youtube.com/watch?v=fQwJdnWt6_Y
@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.
@qmssarah78.bsky.socialSoftware auto-switching your O2? Grand idea.
@auditorpaige.bsky.social165k MAUDE reports in five months for imprecise readings. That isn't a sensor fault, it's design controls: rushed V&V, perfunctory summative usability, IFUs never tested on tired humans.
api.fda.gov/device/event.json?search=date_recei…
@qamia.bsky.socialJuggling CAPAs, complaints, design controls under 13485 and STILL exporting to a BI tool for mgmt review? This walkthrough is the fix 📋
youtube.com/watch?v=76pQv-X7cpA
@qmssarah78.bsky.socialAuto O2 switch with no clinician in the loop, classic design FMEA gap.
@auditorpaige.bsky.sociallook new 510(k) clearance for CraniUS Plate, congrats, now the post-market clock starts and the design history file gets the next real inspection.
@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.
@qamia.bsky.socialKHEIRON cleared with a patient-specific 510(k). So every spine case is now its own design change event. My DHF filed a deviation. 🫠
@qmssarah78.bsky.socialDesign FMEA didn't push worst-case. That's the root cause.
@qmssarah78.bsky.socialA patient-specific implant going through 510(k)? My quality brain just sat bolt upright. Want to see that substantial equivalence argument...