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.

Today, AAMI honors the more than 16 million living U.S. veterans for their service to our nation and for their impact ac...
11/11/2025

Today, AAMI honors the more than 16 million living U.S. veterans for their service to our nation and for their impact across our professional communities.

Many veterans bring their spirit of service into healthcare,
advancing safety and innovation every day.

At AAMI, we are proud to count veterans among our staff, board, members, and broader community.

We are deeply grateful for their contributions to our mission to advance safety in health technology.

This Veterans Day, we proudly spotlight Richard L. “Monty” Gonzales, a U.S. Army veteran and co-founder of the College of Biomedical Equipment Technology.

Alongside fellow veterans, Monty has built an institution where 85% of students are also veterans. He empowers HTM professionals through education, certification, and career development.

Monty’s leadership and service continue to strengthen the HTM community
and AAMI’s mission to advance safety in health technology.

To Monty and to all veterans in the AAMI community: thank you.
Your service, both past and present, makes a lasting difference.

Learn more about Monty’s life of service here: https://tinyurl.com/mtzyafte

The AAMI Foundation’s Franklin Scholarship is accepting applications until January 15, 2026! We’re giving $3,000 toward...
11/10/2025

The AAMI Foundation’s Franklin Scholarship is accepting applications until January 15, 2026!

We’re giving $3,000 towards master’s degrees in:

Business
Public Health
Health Care Administration
Anything else that’ll help you become a healthcare leader!

We’ll need your transcript, a short 500-700 word essay and two letters of recommendation.

Winners will be notified on March 15.

APPLY HERE: https://www.surveymonkey.com/r/6KFSS7R

11/07/2025

New to medical devices or need a refresher on FDA quality system requirements?

Join AAMI’s Quality Systems Foundation course — a virtual, two-day program held January 21–22, 2026, from 11:00am–3:00pm EST.

Learn the fundamentals of FDA’s Quality System Regulation and ISO 13485:2016, which will be incorporated into the upcoming Quality Management System Regulation (QMSR).

Gain clarity on key quality concepts, risk management, validation types, and management responsibilities that ensure a compliant and effective QMS.

💡 Key takeaways:

⚙️ Understand FDA & ISO Requirements

🧩 Master Core QMS Principles

📊 Clarify Validation & Risk Management

🚀 Build Confidence in Compliance

Whether you’re new to the field or an industry veteran seeking a refresher, this course delivers the tools and confidence to address real-world QMS challenges.

👉 Learn more and register here: https://tinyurl.com/58r723sx

11/06/2025

Feeling the pressure of HTM accreditation compliance?

Take control with AAMI’s Mastering HTM Accreditation Compliance course. It’s a virtual training on January 27 & 29, 2026 from 1:00–3:00 PM EST via Zoom.

Learn the latest updates from The Joint Commission’s new Standards overhaul, designed to reduce regulatory burden and better align with CMS.

A key focus is on Alternate Equipment Management (AEM) — understanding evaluation criteria, documentation, and implementation for real-world success.

💡 Key takeaways:

🏥 Simplify Accreditation Compliance

⚙️ Implement Effective AEM Programs

📋 Drive Continuous Survey Readiness

💪 Reduce Stress, Improve Results

Led by Al Gresch, VP of HTM Consulting at Phoenix Data Systems and Chair of AAMI’s Healthcare Technology Leadership Committee, this session delivers actionable insights from one of the field’s top experts.

Ideal for HTM leaders, hospital regulatory professionals, and healthcare executives overseeing Clinical/Biomedical Engineering teams.

👉 Learn more and register here: https://tinyurl.com/yndbt98r

11/05/2025

Are you new to sterilization processes or looking to strengthen your understanding of industrial sterilization for medical devices?

Join AAMI’s Industrial Sterilization for Medical Devices. It’s a 4-day virtual course running January 27–30, 2026, from 9:00am–6:00pm EST.

You’ll gain hands-on experience designing and comparing validation processes for moist heat, ethylene oxide (EO), and radiation sterilization.

💡 Key takeaways:
🧪 Master Core Sterilization Methods
⚙️ Design Effective Validation Processes

📈 Apply FDA & ISO Requirements

🚀 Strengthen Product Quality & Safety

Design and process engineers, operations managers, QA and regulatory professionals, and technicians will get a lot out of this course.

👉 Learn more and register here: https://tinyurl.com/38fbwser

11/05/2025

Are you ready for the new FDA Quality Management System Regulation (QMSR)?

We’re offering our flagship QMSR course, Navigating and Implementing the Requirements: November 17-21, 9:00am–6:00pm EST (final day ends at 1:00pm).

We'll help you apply the FDA’s amended 21 CFR 820 and ISO 13485:2016 and give you tools to achieve full compliance before next year.

You’ll learn to:

⚙️ Implement a Risk-Based QMS

📘 Align with ISO 13485:2016

🧭 Prepare for 2026 Compliance

💡 Apply QMSR in Practice

Developed by FDA-level, world-class quality system experts, it's the best QMSR course around.

Don’t wait until 2026. Prepare now to ensure your QMS meets the FDA’s new expectations and drives product quality across your organization.

👉 Learn more and register here: https://tinyurl.com/4pwj758f

11/05/2025

Two years ago, AAMI published ANSI/AAMI ST108, the groundbreaking standard on the quality of water used to reprocess medical devices.

Today, there is new AAMI guidance on applying ST108 in progress. Hear Terra Kremer, PhD. of Johnson & Johnson discuss efforts to get the forthcoming TIR119 out as soon as possible.

To listen to the full conversation – also featuring Dr. Erin Kyle of AORN, Terra Kremer, PhD. of J&J, and Herb Kaiser, PhD., of STERIS – click here: https://www.youtube.com/watch?v=IGsb8SNcPfs

11/03/2025

Your software needs to fit the FDA’s validation requirements. That’s why we’re offering a Production & Quality System Software course.

It’s a two-day virtual training set for November 12-13, 9:00am-6:00pm EST. You’ll learn to validate your quality management and manufacturing software.

Gain practical knowledge to ensure compliance with FDA 21 CFR 820, ISO 13485, and MDSAP standards.

You’ll discover how to:
✅ Determine which software requires validation — and which doesn’t
✅ Apply lifecycle processes to calibration, QMS, and production systems
✅ Use tools from ISO 80002-2 and GAMP/GPSV frameworks
✅ Validate enterprise, custom, OTS, spreadsheet, and cloud-based software

This course is ideal for software developers, quality engineers, auditors, process and manufacturing engineers, and QA/regulatory professionals.

Walk away with the skills and confidence to validate your systems efficiently and effectively, ensuring compliance across every process.

👉 Learn more and register here: https://tinyurl.com/4avyz54f

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/

Address

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

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

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