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.

10/31/2025

It’s time for a Learning Lineup – Halloween edition! Kick off the new year strong with three expert-led trainings designed to simplify compliance, strengthen systems, and reduce stress.

🧠 FMEA Without Tears

Dec 11, 2025 | Virtual | 1–3 PM ET
Learn how to apply Failure Mode & Effects Analysis without the headaches.
Discover simplified, practical methods that make FMEA fast, credible, and effective.

🏛 Quality Systems Foundation

Jan 21–22, 2026 | Virtual | 11 AM–3 PM ET
Build a strong foundation in FDA and ISO 13485 quality system requirements.
Gain clarity on QMSR expectations and leave ready to tackle QMS challenges with confidence.

🏥 Mastering HTM Accreditation Compliance: Stress Less, Achieve More

Jan 27 & 29, 2026 | Virtual | 1–3 PM ET
Learn strategies to meet and exceed compliance standards in healthcare technology management.
Understand AEM, regulatory expectations, and how to stay survey-ready year-round.

👉 Ready to lead with confidence? Register now!
Aami.org/public-training/

Happy Halloween!

We’re looking for talent, wisdom, and passion in our next group of AAMI HTM mentors. If you’re... -A health tech worker ...
10/30/2025

We’re looking for talent, wisdom, and passion in our next group of AAMI HTM mentors. If you’re...

-A health tech worker with 5 years of experience

- Free for an hour each month

- Looking to grow the next generation of health tech workers

- An AAMI Member

We’d love for you to help us give our growing list of interested protégés a hand up in the industry.

Here’s what AAMI protégés say about the program’s impact:

Of her mentor, Larry Hertzler: “a wealth of knowledge and a fantastic resource... I also enjoy the conversations during our meetings and feel more confident after every meeting.” - Thiri Mon, student at Medisend College

“I’m especially grateful for Dr. Michael O’Conner’s guidance—he’s been an exceptional mentor. Through his support and advice, I was able to secure a job offer, which has been a major milestone for me.” - Wisdom Amenyo, a student at the University of Toronto

And from AAMI’s Vice President of HTM, Danielle McGeary: “The HTM Mentorship Program is a great chance for HTM community leaders to give back to the field they have served in for years. Programs like this are essential to ensuring we have a strong next generation of HTM professionals.”

Help us raise the talents that are destined to bring HTM to new heights. To learn more: https://aami.org/mentorship-program/

AAMI & TechNation’s 2025 State of HTM Survey closes tomorrow, October 31! If you’re a BMET, clinical engineer, service p...
10/30/2025

AAMI & TechNation’s 2025 State of HTM Survey closes tomorrow, October 31!

If you’re a BMET, clinical engineer, service provider or HTM leader, we'd love your input on salary, work conditions, demographics, certification and more!

Don’t miss out — take the survey today and make sure your experience is represented: https://www.surveymonkey.com/r/8KRSPN8

10/30/2025

Are you a medical device professional looking to strengthen your understanding of global standards and how they drive product lifecycle success?

Join us this December 1–5, 2025, for AAMI’s Strategic Standards Management and Participation for Product Lifecycle Success.

🕓 Schedule: Five 4-hour days | 11:00am–3:00pm EST
💻 Format: Virtual

AAMI faculty and FDA representatives help you explore how to strategically use and influence standards across your organization.

We’ll teach you to:
✅ Apply standards across all phases of product development and market introduction
✅ Identify and manage gaps when standards change
✅ Differentiate between national, regional, and international standards bodies
✅ Participate effectively in standards committees and working groups
✅ Ensure ongoing compliance with evolving quality system regulations

Expect engaging discussions, case studies, and practical exercises designed to help you confidently navigate the world of medical device standards.

Who should attend:
Regulatory affairs professionals, quality managers, product development engineers and business or tech leaders who play a role in standards compliance or development.

📘 Participants receive digital course materials, key FDA resources, and a comprehensive list of medical device standards and references.

Take the next step in aligning your organization’s standards strategy with global regulatory expectations.

👉 Learn more and register here: https://tinyurl.com/hkr5wucu

Know someone making big moves in Health Tech? The 2026 AAMI & AAMI Foundation Awards and the AAMI Fellows Program are of...
10/29/2025

Know someone making big moves in Health Tech? The 2026 AAMI & AAMI Foundation Awards and the AAMI Fellows Program are officially open for nominations!

From now until January 15, we’re searching for competitive nominees. Our awards, grants and scholarships cast a wide net for high performers in HTM, BMET, standards, sterilization, cybersecurity and more!

Here’s this year’s lineup:

Laufman-Greatbatch Transformational Impact Award
Honors transformative contributions advancing healthcare technology and patient safety worldwide.

John D. Hughes HTM Leadership Award (sponsored by TRIMEDX)
Recognizes HTM professionals who exemplify innovation, mentorship, and dedication to advancing patient safety and technology management.

Robert L. Morris Humanitarian Award (in partnership with ACCE)
Celebrates the use of healthcare technology to improve global human conditions.

Michael J. Miller Scholarship Program
Supports students pursuing careers as biomedical equipment technicians or in health tech engineering.

Kilmer Scholarship Fund
Awarded to individuals pursuing microbiological quality and sterility assurance professions.

BMET of the Year Award (sponsored by GE Healthcare)
For excellence, achievement, and dedication in the BMET profession.

Cybersecurity Visionary Award (sponsored by MedCrypt)
Honors visionaries tackling critical medical device cybersecurity challenges.

HTM Association of the Year Award
Honors associations that elevate the HTM profession through strong operations and local impact.

Sterilization Science Award
For significant and sustained contributions to sterilization, sterility assurance, and contamination control.

Standards Developer & Technical Committee Awards
Recognizes exceptional efforts in standards development and committee leadership.

AAMI Foundation Kilmer Research Grant
Supports groundbreaking research in microbiological quality and sterility assurance.

And more!

We want to highlight the industry’s best and brightest. And it all starts with you. Nominate here before January 15: https://aami.org/awards/

10/29/2025

Do you validate production or quality system software in the medical device industry?

We’re running a Production & Quality System Software course.

📅 When: November 12–13, 2025
💻 Format: Virtual
🕘 Schedule: Two 8-hour days | 9:00am–6:00pm EST

We’ll help you distinguish what software requires validation under FDA 21 CFR 820, ISO 13485, and MDSAP, and walk you step-by-step through the software lifecycle process.

You’ll learn how to:
✅ Identify which types of software require validation — and which do not
✅ Apply lifecycle processes to production, calibration, and QMS software
✅ Use tools and guidance from ISO 80002-2 and GAMP/GPSV frameworks
✅ Validate software efficiently across enterprise, custom-developed, off-the-shelf (OTS), spreadsheet, and cloud-based systems
✅ Align your validation strategies with FDA and ISO expectations

Who should attend:
Software developers, quality engineers, auditors, process and manufacturing engineers, QA and regulatory professionals!

Gain the knowledge, tools, and techniques to ensure your production and QMS software meets the highest standards of compliance and performance.

👉 Learn more and register here: https://tinyurl.com/hvmfwfjs

AAMI team members Claudia Daley and Darren Robertson were proud to join forces with Project C.U.R.E on their hospital be...
10/28/2025

AAMI team members Claudia Daley and Darren Robertson were proud to join forces with Project C.U.R.E on their hospital bed initiative—delivering donated beds to hospitals and clinics in underserved communities across the U.S., developing countries, conflict zones, and disaster-stricken areas.

🚚 Phase One: Nearly 500 beds are arriving at Maryland warehouses, and volunteers are needed to help receive and unload them.

📦 Phase Two: These beds will be prepared for shipment in containers bound for facilities worldwide.

Project C.U.R.E continues to have a life-saving impact by providing essential medical equipment and supplies to those in need. AAMI is honored to support this critical mission.
Special thanks to Janet K. Thomas for the opportunity and to Danielle McGeary for leading the AAMI effort!

Our Amsterdam QMSR Course is 25% OFF* for THREE MORE DAYS! We’re taking our flagship training to Amsterdam, Netherlands...
10/27/2025

Our Amsterdam QMSR Course is 25% OFF* for THREE MORE DAYS!

We’re taking our flagship training to Amsterdam, Netherlands in just two weeks! Learn how to implement and maintain a risk-based QMS that meets the FDA’s amended 21 CFR 820 and ISO 13485:2016 requirements.

📍 Location: Hyatt Place Amsterdam Airport, Netherlands
📅 Dates: November 3–7, 2025
🕗 Schedule: Four 8-hour days (8:00am–5:00pm CET) + One 4-hour day (8:00am–12:00pm CET)

We built this course alongside FDA experts, leading device manufacturers, ISO standards developers, and seasoned industry consultants.

Our world-class faculty with 30+ years of experience will teach you to:
✅ Implement and maintain a compliant, risk-based QMS
✅ Conduct a gap assessment to ensure readiness before the February 2, 2026 deadline
✅ Integrate QMSR and ISO 13485 into design, labeling, software, and production processes
✅ Strengthen risk-based thinking across your organization

Don’t wait until 2026.
Join us in Amsterdam and prepare your organization for the future of medical device quality management. To register: https://tinyurl.com/24h2umua

*Offer may be combined with other discounts to a 25% maximum.

10/23/2025

We're proud to support GECA’s ICEHTMC conference in Shenzen, China! AAMI delivered keynotes from President & CEO Pamela Arora as well as Chief Learning & Development Officer Robert Burroughs and Vice President of Healthcare Technology Management Danielle McGeary!

Here's a look at the conference, courtesy of Yadin David & Tom Judd.

10/23/2025

It’s U.S. World Standards Day! Hear from President & CEO Pamela Arora on the profound impact of standards on the world of healthcare.

Happy World Standards Day (U.S)! We're proud to work with great organizations in the MedTech sphere to set the standards...
10/23/2025

Happy World Standards Day (U.S)! We're proud to work with great organizations in the MedTech sphere to set the standards that matter.

How do you reduce service complexity and improve clinical uptime across a hospital network? In our latest Company Spotli...
06/18/2025

How do you reduce service complexity and improve clinical uptime across a hospital network?

In our latest Company Spotlight, PartsSource CEO Phil Settimi shares how the enterprise platform transforms over 5,000 hospitals to manage parts, service, and supply chain operations.

Hear how organizations like Mayo Clinic and HCA use these tools to improve clinical availability. Stop by Booth 2837 at AAMI eXchange to see it in action!

https://www.youtube.com/watch?v=ikRYWBguu2g

https://corporate.partssource.com/aami-2025/

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

Telephone

+17035254890

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