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.

01/21/2026

LAST CHANCE! AAMI is offering a 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

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

You’ve got ONE MONTH LEFT to nominate for the Mary K. Logan Research Grants and the AAMI Foundation’s Kilmer Research Gr...
01/20/2026

You’ve got ONE MONTH LEFT to nominate for the Mary K. Logan Research Grants and the AAMI Foundation’s Kilmer Research Grant!

The Mary K. Logan Research Grants fund explorations into device innovation, clinical processes, sterilization, dialysis, human factors, HTM, or other critical technology challenges.

The Kilmer Research Grant funds individuals or teams who push the field forward through rigorous methodology and interdisciplinary collaboration.

Nominate and learn more here: https://aami.org/awards/aami-awards/

01/20/2026

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



We’re offering our flagship QMSR course, Navigating and Implementing the Requirements: March 16-20, 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

🧭Ensure 2026 Compliance

💡 Apply QMSR in Practice



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

👉 Learn more and register here: https://tinyurl.com/4s8zcma2

01/19/2026

Are you a regulatory or quality leader preparing to bring a new medical device to the U.S. market?

Check out AAMI’s Navigating 510(k) & De Novo Requirements course. It’ll help you confidently navigate the FDA submission process and accelerate time to market.

📅 When: March 10-13, 2026
💻 Format: Virtual
🕘 Schedule: Four 8-hour days | 9:00am–6:00pm EST

Whether you’re managing new technologies, mobile health apps, or next-generation medical devices, this training gives you peace of mind when submitting your proposal.

📄 Master FDA Submission Requirements

⚙️ Streamline Design-to-Market Pathways

🚀 Accelerate Clearance & Reduce Rework

🧭 Build In-House Regulatory Expertise

If you work in quality/regulatory affairs, manufacturing or just want to rely less on outside consultants, this course is for you!

👉 Learn more and register here: https://tinyurl.com/5t4x9c4x

01/19/2026

AAMI’s Industrial Sterilization for Medical Devices course covers sterilization technologies, FDA requirements and key standards for sterilization validation and product release.

It’s a 4-day virtual experience running January 27–30, 2026, from 9:00am–6:00pm EST.

💡 Key takeaways:

🧪 Master Core Sterilization Methods

⚙️ Design Effective Validation Processes

📈 Apply FDA & ISO Requirements

🚀 Strengthen Product Quality & Safety

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

HTM’s workforce crisis isn’t inevitable. Guest author Courtney Kinkade of TRIMEDX explores how advocacy, smart partners...
01/16/2026

HTM’s workforce crisis isn’t inevitable.

Guest author Courtney Kinkade of TRIMEDX explores how advocacy, smart partnerships, and cross-team collaboration can rebuild the talent pipeline.
This article is part of the “Troubleshoot it!” HTM news series. To read more and view all articles from the AAMI newsroom, visit aami.org/news .

01/16/2026

Do you work with medical devices and want to ensure your products are safe, intuitive, and aligned with FDA expectations?

We're offering a Human Factors for Medical Devices course.

🕘 Schedule: March 9-11 | 8:00am–5:00pm EST
💻 Location: Arlington, VA

FDA representatives from CDRH and CDER and seasoned AAMI experts will walk you through integrating human factors engineering into your device design & development.

You’ll be able to:
✅ Apply user modeling and task analysis to identify and mitigate use-related risks
✅ Conduct formative and summative usability testing aligned with FDA expectations
✅ Implement methodologies such as contextual inquiry and heuristic evaluations
✅ Understand and apply human factors standards like ANSI/AAMI/IEC 62366-1:2015
✅ Incorporate human factors into pre-market submissions and post-market evaluation

Who should attend:
Quality and design engineers, R&D managers, risk managers, regulatory and QA professionals, clinical affairs specialists, and new human factors engineers.

📘 Registration includes a copy of ANSI/AAMI/IEC 62366-1:2015, FDA guidance documents, industry references, and an interactive eNotebook of all course materials.

Let’s design medical devices that truly meet the needs of users and patients – together.

👉 Learn more and register here: https://tinyurl.com/w5dr3vau

01/15/2026

Ready to strengthen risk-based decision-making across the entire medical device lifecycle?

Join AAMI’s Integrating Risk Management into the Product Life Cycle — a virtual, three-day course on February 4–6, 2026, from 9:00am–6:00pm EST.

Gain insights from AAMI faculty and FDA representatives on expectations for submissions, audits, and risk-based QMS processes.

You’ll learn how to:

Apply risk management from design through post-market

Use ISO 14971 tools for practical decision-making

Connect risk processes to QMS requirements

Leverage regulatory databases and safety standards

Designed for manufacturers, QA/RA professionals, engineers, operations managers, supplier quality staff, and R&D teams.

👉 Learn more and register here: https://tinyurl.com/48n4jw63

The AAMI Awards Deadline is TODAY! It’s your last chance to nominate yourself (award dependent) or a colleague for one o...
01/15/2026

The AAMI Awards Deadline is TODAY! It’s your last chance to nominate yourself (award dependent) or a colleague for one of the honors!

We’re honoring standouts in HTM, sterilization, standards development and so much more!

You can find the full list here: https://aami.org/awards/

01/14/2026

The Joint Commission has made some major changes to its HTM standards. Is your department still compliant?

In this episode of AAMI’s HTM podcast, "Basement to Bedside," we interview Kenneth Colavito and henry stankiewicz of Sigma Health Consulting, LLC about what you should expect from Joint Commission.

Check out the full episode for more on managing HTM capital planning, a review of AAMI’s HTM activities from 2025, and a preview of the Dental Pavilion at the 2026 AAMI eXchange in Denver.

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