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@icon-plc.bsky.socialSep 21, 2026, 3:00 PM

ICON is proud to be Platinum Sponsor of the TOPRA Symposium 2026.
Join us and the regulatory affairs community at the Royal Jaarbeurs in Utrecht from 19 to 21 October and visit ICON’s team at booth #37.
Learn more: https://ow.ly/VhCR50ZIN65

#RegulatoryAffairs #TOPRASym26

@samqadani.bsky.socialSep 21, 2026, 5:16 AM

thrown into a qms rloe with no iso 13485 background? The validated process templates carry you. #MedicalDeviceQMS #ISO13485 #qmsWrapper #AuditReady #QualityManagement #RegulatoryAffairs...
youtube.com/watch?v=S2YB68oZdCE

@regafraid.bsky.socialSep 17, 2026, 3:43 PM

QSIT rewards calm preparation. MDR agrees.

#RegulatoryAffairs #MDRCompliance #AuditReady

@citiprogram.orgSep 16, 2026, 4:03 PM

If you're attending the 2026 RAPS Convergence in Charlotte, we'd love to meet you! Stop by booth # 1010 in the exhibit hall to learn more about our research training solutions and how they can support your organization.
#RAPS2026 #RAPSConvergence #RegulatoryAffairs

@dnanexus.bsky.socialSep 14, 2026, 4:03 PM

We’re excited to join our partners in Frankfurt this week for LORENZ Converge! Meet with us to see how together with LORENZ we're enabling streamlined regulatory collaboration through our TRS platform.

#LORENZConverge #RegulatoryAffairs #LifeSciences #RegulatoryScience #DNAnexus

Meet Us at LORENZ Converge! September 14-16, 2026. Frankfurt, Germany. See us to learn about TRS, the regulatory-grade cloud environment where sponsors, agencies, and standards organizations collaborate earlier, exchange information securely and prepare for structured submission workflows.
@icon-plc.bsky.socialSep 14, 2026, 9:00 AM

The EU AI Act, evolving FDA expectations and emerging global frameworks are reshaping AI-enabled medical device development. Our new whitepaper provides practical guidance for navigating the changing landscape. https://ow.ly/3w3m50Zypik

#MedicalDevices #AI #RegulatoryAffairs #DigitalHealth

@regaffairsyuki.bsky.socialSep 12, 2026, 4:38 AM

Medline kit recall, Class II because of downstream procedure risk, but the root cause (gen'in) sits upstream with the component maker. Kit assemblers inherit the recall burden; supplier and the CAPA queue is where this actually gets tested...

#Traceability #SupplierQuality #RegulatoryAffairs

@qamia.bsky.socialSep 12, 2026, 1:03 AM

TAVR coverage expanding to asymptomatic patients means someone's CER, risk file, and PMS plan just became a change control nightmare 🫠

#RiskManagement #RegulatoryAffairs #ChangeControl

@citiprogram.orgSep 8, 2026, 3:03 PM

We're excited to be exhibiting at the 2026 RAPS Convergence! Be sure to visit us to learn how our regulatory training solutions can support your organization's goals. We look forward to meeting you in Charlotte!
#RAPS2026 #RAPSConvergence #RegulatoryAffairs

@qmssarah78.bsky.socialSep 8, 2026, 2:55 PM

Medline Class II recall of convenience kits proves rapid and automated CAPAs are non-negotiable, delays risk patients.

#CAPA #RegulatoryAffairs #Traceability

@nutrimarkets.bsky.socialSep 8, 2026, 1:20 AM

Colombia INVIMA Crackdown: 9 Lists of FRAUDULENT Supplements! #INVIMA #ColombiaSupplements #RegulatoryAffairs

Watch the full video: https://nutri.markets/academy/video/colombia-invima-crackdown-9-lists-of-fraudulent-supplements-x0vFcf_d45A

@qmssarah78.bsky.socialSep 7, 2026, 2:14 PM

AI devices demand audit-ready change control

#AuditReady #ChangeControl #RegulatoryAffairs