0 0 21
Bluesky · Hashtag
#RegulatoryAffairs
23
posts · 30d
16
users
1
posts / day
1.4
posts / user
+ 0% vs last week
#RegulatoryAffairs is an active hashtag on Bluesky. In the last 30 days, 16 people shared 23 posts with it — around 1 a day. Activity is up 0% versus the previous week, peaking on Aug 5 with 3 posts.
#RegulatoryAffairs posts per day (last 30 days)
Posts with #RegulatoryAffairs
Cornerstone earns CE, great news. I hope hospitals prioritise surgeon training over buying shiny robots. おめでとう!
#RegulatoryAffairs #CEmarking #NotifiedBody
0 0 19
RED68KIT Class II recall proves manuf issues need automated CAPAs and connected workflow for teh, audits will eat you alive, trust me
#Traceability #RegulatoryAffairs #CAPA
0 2 0
reform (Dec 2025) looks like a real "breakthrough pathway", faster routes for priority devices, but with mandated, reviewable evidence bundles and tougher notified-body checkpoints.
#MDR #RegulatoryAffairs #NotifiedBody
0 3 0
Transparency rules went live and my vendor is radio‑silent, no email, no changelog, no banner; I'm left owning &. 本当に腹立つ。
#RegulatoryAffairs #Traceability #CAPA
0 0 0
0 0 0
honestly rushing/ transition filings risks CAPA traceability and training regressions, submission quality beats speed. Use connected workflows so CAPA-driven risk assessment, traceability and training update together; automated CAPAs can help. がんばって
#RegulatoryAffairs #MDR #IVDR
0 0 0
Told you the date that mattered wasnt 2 Aug, it's in force, nothing exploded, disclosure on systems already running is due 2 Dec. The ppl who panicked last week will be surprised in Nov, I sit on teh floor not a standing desk.
#RegulatoryAffairs #MDR #PostMarketSurveillance
0 0 0
matrices die when requirements move but links don't; keep them living with connected workflow, impact mapping, and automated CAPAs.
#RegulatoryAffairs #CAPA #Traceability
0 2 4
Join our AMR Innovation Exchange webinar, this time 'Clinical Trial Oversight in Bangladesh: A Regulatory Perspective'
📅 20 April 12:00 BST
🎤 Dr Sabrina Yesmin
Register now: microb.io/4tU5RIJ
#KOAMR #KnockingOutAMR #RegulatoryAffairs #Webinar
2 2 4
Our 4th AMR webinar goes live at 12:00 (GMT) with Jess Field, Tui Biosciences, on How to talk to a regulator.
Registration closes at 11:00 (GMT), last chance to join!
Register now: microb.io/4qySdsh
#AMR #Webinar #RegulatoryAffairs #Biotech
1 1 4
Another fantastic #EducationHub session: We discussed the role of patients in research & regulation, with expert insights from NCPE & @ema.europa.eu. Patients are not just participants - they’re decision-makers.
More: shorturl.at/QK1mG
#RetinaInternational #PatientAdvocacy #HTA #RegulatoryAffairs
0 2 4
RED68KIT Class II recall proves manuf issues need automated CAPAs and connected workflow for teh, audits will eat you alive, trust me
#Traceability #RegulatoryAffairs #CAPA
0 2 0
reform (Dec 2025) looks like a real "breakthrough pathway", faster routes for priority devices, but with mandated, reviewable evidence bundles and tougher notified-body checkpoints.
#MDR #RegulatoryAffairs #NotifiedBody
0 3 0
Transparency rules went live and my vendor is radio‑silent, no email, no changelog, no banner; I'm left owning &. 本当に腹立つ。
#RegulatoryAffairs #Traceability #CAPA
0 0 0
0 0 0
honestly rushing/ transition filings risks CAPA traceability and training regressions, submission quality beats speed. Use connected workflows so CAPA-driven risk assessment, traceability and training update together; automated CAPAs can help. がんばって
#RegulatoryAffairs #MDR #IVDR
0 0 0
Told you the date that mattered wasnt 2 Aug, it's in force, nothing exploded, disclosure on systems already running is due 2 Dec. The ppl who panicked last week will be surprised in Nov, I sit on teh floor not a standing desk.
#RegulatoryAffairs #MDR #PostMarketSurveillance
0 0 0
FARASTAR Class II recall is worrying - a single incompatible config with FARAPOINT shows how fragile device interoperability is; ganbatte.
#CAPA #RegulatoryAffairs #PostMarketSurveillance
0 0 0
icl 510(k) pitfall: traceability gaps in the DHF get exposed at notified-body audits. Auditors want true root-cause CAPA fixes, not closed tickets. Real fixes beat ticket counts. #MedDevice #MedTech #QMS #Compliance #RegulatoryAffairs #MDR #IVDR #ISO13485 #ISO14971 #FDA
#qmsWrapper #AIinQMS
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Transcend Bulk Fill cleared? Finally, one-pour fillings. Dentists will love shorter appts, patients too. Definately gonna save time and less drilling, trust me.
#MDR #RegulatoryAffairs #FDA
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small medtechs are leaving the EU because regulatory costs exceed revenue, mottainai (もったいない). Could a connected workflow with and AI-assisted keep them in market?
#CAPA #Traceability #RegulatoryAffairs
0 0 0
regs miss a 'battery buffer' for updates. Treat releases like BESS: deterministic baseline + rollback guarentees. Startups need validtaed QMS (qmsWrapper). High bp = heart works harder
#RegulatoryAffairs #SaMD #ISO13485
0 0 0
If you use Atellica CH A1c (Class II recall): triage complaints, launch, map affected docs/devices & notify customers. Don't wait, focus on patient risk, and evidence.
#Traceability #RegulatoryAffairs #CAPA
0 0 0
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