AAMI

AAMI Advancing safety in health technology

AAMI is a diverse community of more than 10,000 professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for health technology and sterilization professionals.

09/04/2026

Prepping for the CBET exam? Got 60 seconds?

AAMI VP of HTM Danielle McGeary and Ryan Gonzalez will be quizzing each other every week on practice questions for both the CBET and CHTM exams.

Test your knowledge on the anatomy & physiology section by watching below!

Please note that these are not actual exam questions. For deeper study, check out some of AAMI's exam prep courses this fall:

CBET: https://aami.org/event/cbet-study-course-online-fall-2026/

CHTM: https://aami.org/event/chtm-study-course-online-october-2026/

Early Bird Registration is NOW OPEN for AAMI neXus 2027 (April 13-16, National Harbor, MD)! Join the medical device comm...
09/03/2026

Early Bird Registration is NOW OPEN for AAMI neXus 2027 (April 13-16, National Harbor, MD)!

Join the medical device community at the annual meeting dedicated to advancing the Development, Adoption, and Application of medical device standards.

Connect with manufacturers, regulators, healthcare delivery organizations, regulatory and government agencies, notified bodies, and industry experts to stay ahead of standards and regulatory developments. It's your moment to help shape what comes next.

If medical device quality, safety, and innovation are central to your work and if you rely on medical device standards in your work a seat at the table waits for you at AAMI neXus 2027.

Register early and save: https://lnkd.in/eDSz3bfJ

Dr. Gerald McDonnell, Monica J. W., Aaron Dunbar, Diane Wurzburger, Fatemeh Razjouyan, Adam N. Vasquez, Scott Colburn, Linda Ricci, Bill Brodbeck Robert Burroughs

Richard Bancroft, Thor Rollins, Pat Baird, Terry Woods, Lena Cordie-Bancroft, Nupur Jain, Steven Bipes

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What does HTM need to become over the next five years, and what must AAMI build, scale, or launch to get it there?30 ama...
09/02/2026

What does HTM need to become over the next five years, and what must AAMI build, scale, or launch to get it there?

30 amazing leaders in HTM joined us for the fourth HTM Future Forum. They represent all corners of HTM, ranging from inspectors and regulators to service providers and your hospitals' fix-it pros.

After two days, the answer that emerged, participants said, was less a single fix and more-so a shift in posture toward standardization, clearer data, and conveying HTM's value as a source of go-to experts for modernizing health systems.

AAMI plans to translate the forum's recommendations into concrete initiatives over the coming months.

Thank you to all our participating Future Forum and leaders! And stay tuned for more good news!

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AAMI's Microbiological Methods Working Group (ST WG-08) just published TIR52:2026 to help device manufacturers establish...
09/02/2026

AAMI's Microbiological Methods Working Group (ST WG-08) just published TIR52:2026 to help device manufacturers establish environmental monitoring programs that demonstrate a product's suitability under microbiological control.

The document emphasizes routine monitoring as part of an overall contamination control strategy, rather than treating terminal sterilization as a substitute for a controlled manufacturing environment.

Read the full article here: https://lnkd.in/eaPmpPXm

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Leverage AI, statistics, and software validation to make smarter decisions across the medical device lifecycle.📅 Septemb...
09/02/2026

Leverage AI, statistics, and software validation to make smarter decisions across the medical device lifecycle.

📅 September 23 | Evaluating AI-Enabled Health Technologies for Safety and Performance

🕛 12:00–3:30 PM ET

👩‍🏫 Faculty: Val Malika Reagon, DrPH, MPH, MLA

🔗 https://tinyurl.com/325crtje

📅 October 7 | Are Your Data Normal...or Not?

🕐 1:00–3:00 PM ET

👩‍🏫 Faculty: Lindsey Howard, Mark Cooksey, Peter Knepell

🔗 https://tinyurl.com/yc8feakp

📅 October 27–29 | Medical Device Software Validation

🕘 9:00 AM–6:00 PM ET

👩‍🏫 Faculty: Brian Pate, David Nelson

🔗 https://tinyurl.com/yc8ch397

AAMI members get 10% OFF all trainings!

Not a member? Become one here: https://aami.org/membership/individual-membership/

Designed for medical device professionals across Europe, AAMI's Quality Management System Regulation (QMSR) – European T...
09/01/2026

Designed for medical device professionals across Europe, AAMI's Quality Management System Regulation (QMSR) – European Time course delivers comprehensive QMSR training on a schedule that works for your time zone.

Gain the knowledge and practical tools to implement FDA's Quality Management System Regulation, align with ISO 13485:2016, and prepare your organization for today's global regulatory environment.

📅 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://tinyurl.com/4ff589zx

Develop practical strategies for implementing risk-based quality systems, preparing for FDA inspections and MDSAP audits, identifying compliance gaps, and strengthening your organization's quality management practices—all in a course designed specifically for professionals serving European markets.

AAMI members get 10% OFF all trainings!

Not a member? Become one here: https://aami.org/membership/individual-membership/

Advance your expertise in quality systems, regulatory strategy, and product development with AAMI's upcoming training.📅 ...
08/31/2026

Advance your expertise in quality systems, regulatory strategy, and product development with AAMI's upcoming training.

📅 September 9–11 | Establishing & Sustaining a Robust Medical Device QMS: Guidance from AAMI EQ56

🕘11:00AM-2:00PM ET

👩‍🏫 Faculty: Herman McKenzie

🔗 https://tinyurl.com/3dvaz7fj

📅 September 9–16 | Combination Products: A Risk-Based Approach

🕘 9:00 AM–6:00 PM ET

👩‍🏫 Faculty: James Webby, Susan Neadle

🔗 https://tinyurl.com/4c6v49e7

📅 September 15–17 | Mastering SaMD: Navigating Regulations & The Product Lifecycle

🕐 1:00–3:00 PM ET

👩‍🏫 Faculty: David Nelson

🔗 https://tinyurl.com/5fp7mazm

📅 September 22–25 | Practical Post Market Surveillance for Medical Devices

🕘 9:00 AM–6:00 PM ET

👩‍🏫 Faculty: Pooja Kartik (she/her), Mary Vater

🔗 https://tinyurl.com/2fkxh4yf

Build practical knowledge in quality systems, combination products, software regulation, and post-market activities to strengthen compliance throughout the medical device lifecycle.

AAMI members get 10% OFF all trainings!

Not a member? Become one here: https://aami.org/membership/individual-membership/

AAMI's Ethylene Oxide Sterilization for Medical Devices – Costa Rica course is designed for experienced EO sterilization...
08/31/2026

AAMI's Ethylene Oxide Sterilization for Medical Devices – Costa Rica course is designed for experienced EO sterilization professionals responsible for optimizing processes, evaluating changes, and maintaining validated sterilization systems.

📅 September 21–24, 2026

🕗 September 21–23: 8:00 AM–5:00 PM | September 24: 8:00 AM–12:00 PM

👩‍🏫 Faculty: Roberto Zumbado

📍 Residence Inn by Marriott San José Escazú, Costa Rica

🔗 https://tinyurl.com/2tmxk7bs

Through real-world case studies and interactive discussions, you'll strengthen your ability to troubleshoot cycle anomalies, determine when validation or requalification is needed, and confidently implement changes to products, equipment, and sterilization processes.

AAMI members get 10% OFF all trainings!

Not a member? Become one here: https://aami.org/membership/individual-membership/

LAST CALL: AAMI neXus 2027 proposals are due TONIGHT @ 11:59 EST! Have insights, research, lessons learned, or practical...
08/31/2026

LAST CALL: AAMI neXus 2027 proposals are due TONIGHT @ 11:59 EST!



Have insights, research, lessons learned, or practical strategies that can move health technology forward? This is your FINAL opportunity to bring them to AAMI neXus 2027, April 13–16 in National Harbor, MD.



We’re looking for proposals across standards and regulation, quality and risk management, care delivery, sterility assurance and biocompatibility, and emerging technologies.



Help shape the conversations defining what’s neXt in health technology as we celebrate 60 years at AAMI.

Submit your proposal: https://tinyurl.com/52usfprr

Dr. Gerald McDonnell, Monica J. W., Aaron Dunbar, Diane Wurzburger, Fatemeh Razjouyan, Adam N. Vasquez, Scott Colburn, Linda Ricci, Bill Brodbeck Robert Burroughs

Richard Bancroft, Thor Rollins, Pat Baird, Terry Woods, Lena Cordie-Bancroft, Nupur Jain, Steven Bipes



We're grateful to welcome John Logar, Sr. Director – MQSA Innovation & External Advocacy at Johnson & Johnson, to the ne...
08/29/2026

We're grateful to welcome John Logar, Sr. Director – MQSA Innovation & External Advocacy at Johnson & Johnson, to the neXus 2027 Advisory Council!

Logar brings deep expertise to help shape a program marking AAMI's 60th anniversary.

Join us, April 13–16, 2027, in National Harbor, MD.

Address

901 N. Glebe Road, Suite 300
Arlington, VA
22203

Opening Hours

Monday 9am - 5pm
Tuesday 9am - 5pm
Wednesday 9am - 5pm
Thursday 9am - 5pm
Friday 9am - 5pm

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+17035254890

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