AAMI

Navigate the EU IVDR with greater confidence—and understand what it takes to bring in vitro diagnostics to the European market. Join AAMI's European Union In Vitro Diagnostics Regulation (EU IVDR) Foundations training to explore Regulation (EU) 2017/746, including QMS requirements, device classification, conformity assessment, performance evaluation, and technical documentation. 📅 April 27 & 29, 2027 🕚 11:00 AM–3:00 PM ET 👨🏫 Seb Clerkin, 🔗 https://lnkd.in/eZmkksKc Apply the IVDR's Annex VIII classification rules, understand requirements beyond ISO 13485:2016, and build a practical gap assessment for your organization. AAMI members get 10% OFF all trainings! #EUIVDR #IVDR #InVitroDiagnostics #RegulatoryAffairs #ISO13485 #MedicalDevices #AAMI

Save the date: AAMI eXchange, June 4-7, 2027 in Fort Lauderdale, Florida! Join your HTM and Sterile Processing peers for four days of networking, learning, and innovating across the industry. Learn more about eXchange and stay updated here: https://lnkd.in/eSTekzQ3 #AAMIeXchange2027

NEW COURSE FROM AAMI! Get grounded in the EU MDR and what it takes to bring medical devices to the European market. Join AAMI's European Union Medical Device Regulation (EU MDR) Foundations training to explore Regulation (EU) 2017/745, including QMS requirements, device classification, conformity assessment, and technical documentation. 📅 February 23 & 25, 2027 🕚 11:00 AM–3:00 PM ET 👨🏫 Seb Clerkin, PhD, RAC (EU), RCC-IVDR 🔗 https://lnkd.in/d78MBNzc AAMI members get 10% OFF all trainings! #EUMDR #MedicalDevices #RegulatoryAffairs #ISO13485 #AAMI

DEADLINE EXTENDED! You’ve got 4 MORE days to bring your ideas to the AAMI eXchange 2027 stage! Share your expertise on AI, cybersecurity, sterile processing, emerging technologies, and more -- June 4–7 in Fort Lauderdale! New deadline: September 22 at 11:59 PM ET. Submit your proposal: https://lnkd.in/eert3RFB #AAMIeXchange2027

European medical device professionals: get QMSR training on a schedule built for your time zone. AAMI's Quality Management System Regulation (QMSR) – European Time course provides practical guidance for understanding and implementing FDA's QMSR while connecting its requirements to ISO 13485:2016 and the broader global regulatory landscape. 📅 September 21–25, 2026 🕘 September 21–24: 9:00 AM–6:00 PM Irish Standard Time | September 25: 9:00 AM–1:00 PM Irish Standard Time 👨🏫 Faculty: Seb Clerkin, PhD, RAC (EU), RCC-IVDR 🔗 https://lnkd.in/eM4he3Xq Learn how to evaluate your QMS against FDA requirements, apply risk-based decision-making, strengthen inspection readiness, and prepare for ISO 13485 and MDSAP audits—all during European-friendly hours. AAMI members get 10% OFF all trainings! Not a member? Become one here: https://lnkd.in/eu6Wzf_B #MedicalDevices #QMSR #ISO13485 #FDACompliance #QualitySystems #RegulatoryAffairs #EuropeanMedTech #MDSAP

You have just ONE WEEK left to submit your session proposal for AAMI eXchange 2027! Whether you’ve been in the field for ten months or ten years, we want to hear the lessons you’ve learned, challenges you’ve solved, and ideas that could move HTM, sterile processing, and health technology forward. Topics include AI, cybersecurity, workforce development, leadership, health technology innovation, sterile processing, vendor collaboration, and more. Build your professional credibility, earn CEUs, and share your perspective with 2,000+ professionals. 📅 Deadline: Friday, September 18 at 11:59 PM Submit your proposal: https://lnkd.in/eAyM9wRX #AAMIeXchange #HTM #SterileProcessing #HealthTechnology