AAMI

01/29/2026

Managing change in an established ethylene oxide sterilization process can be complicated.

AAMI’s Ethylene Oxide Sterilization for Medical Devices is here to help.

It’s a 3.5-day, IN-PERSON advanced course held March 3–6, 2026, in our Arlington, Virginia office.

Designed for experienced EO professionals, this interactive program focuses on process optimization, change assessment, and troubleshooting in real-world sterilization environments.

You’ll learn how to:

⚙️ Assess changes to product, process, or equipment

🧪 Determine validation or requalification needs

🔍 Troubleshoot cycle anomalies

🚀 Improve turnaround time and effectiveness

Ideal for professionals responsible for EO process decisions, validation, requalification, and failure investigation.

Through case studies and situational analysis, you’ll apply concepts directly to real EO sterilization challenges.

👉 Learn more and register here: https://tinyurl.com/5424eat6

01/28/2026

Water quality massively impacts the safety and effectiveness of medical device processing. Want to know how?

AAMI’s Navigating ANSI/AAMI ST108:2023 – Guidance for Water Quality on February 9, 2026, from 1:00–3:00 PM ET, delivered live online.

This training introduces the newly established ANSI/AAMI ST108:2023 standard, offering clear guidance on water requirements for the processing of reusable medical devices.

💧 Understand water quality’s role in safe device reprocessing

📋 Identify key requirements for maintaining compliant water systems

🚨 Recognize and communicate risks when water quality issues arise

Ideal for sterile processing professionals, clinical engineers, facilities engineering teams, infection preventionists and procedural staff.

👉 Learn more and register here: https://tinyurl.com/d94ddz3m

01/28/2026

Want to improve how you write and communicate in medical device regulatory documents?

Join AAMI’s Regulatory Writing for Medical Devices Workshop. It’s a virtual, three-day program running February 17–19, 2026 from 11:00am–1:00pm EST.

💡 You’ll learn how to:

✍️ Write clear, compliant documentation that conveys the intended message

🧠 Differentiate document types and understand their regulatory purposes

🧾 Meet stakeholder expectations across internal and external audiences

🚀 Strengthen communication skills for QMS and product safety submissions

Led by Tiea Theurer, Consultant at Quarem Consultant, this workshop is ideal for professionals new to regulatory writing or looking to refine their skills.

If you’re involved in creating documentation for quality systems or product submissions, this course will help you write with precision, confidence, and compliance in mind.

👉 Learn more and register here: https://tinyurl.com/39denurv

01/28/2026

Though women comprise 18% of HTM professionals, 22% of HTM leaders and managers are women!

This trend suggests the industry is retaining female professionals at a higher rate into leadership.

For more 2025 industry insights, please read AAMI and TechNation’s State of HTM Workforce: Integrated 2025 Survey Analysis.

Access the free report here: https://tinyurl.com/44ndhz4a

01/27/2026

Are you a software engineer looking to align your product with global healthcare standards?

We’re offering a 3-day MDSV course (February 10-12, 2026) that’ll speed you ahead in the evolving world of medical device software.

Through a mix of lectures and real-world case studies, you’ll learn to:

✅ Apply key laws, regulations, and standards (21CFR820, ISO 13485, ANSI/AAMI/IEC 62304, ISO 14971, and more)
✅ Understand software classification and related validation activities
✅ Navigate FDA and EU submission requirements
✅ Incorporate cybersecurity and post-market expectations into your process

Let’s bring our medical software to new frontiers, together.

👉 Learn more and register here: https://tinyurl.com/564nxece

01/27/2026

Don’t just attend—engage at AAMI neXus (EARLY BIRD ENDS February 27!)

This is where healthcare technology conversations come alive, with real dialogue shaping the future of standards, regulation and innovation.

No sidelines. No passive sessions. Just meaningful exchange with the people driving change.

Early bird registration ends February 27. Learn more and register here: https://lnkd.in/eRAa_T64

01/26/2026

Want to design better medical devices and strengthen the human factors foundation behind them?

Join AAMI’s ANSI/AAMI HE75:2025 Unleashed — a two-day virtual training on February 18–19, 2026, from 12:00–3:00 PM ET.

MaryBeth Privitera, PhD, FIDSA will walk you through the brand-new HE75:2025, the first major update to AAMI’s premier human factors engineering standard in more than 15 years.

Learn how to apply this newly revised, 500+ page standard to strengthen design decisions, usability testing and FDA-aligned human factors practices.

You’ll learn how to:

- Apply HE75 to fit & function for your specific user group

️- Implement design best practices across devices, labeling, software, packaging, home use products, and integrated systems

- Strengthen risk management & usability testing using HE75 guidance

Ideal for design engineers, human factors specialists, and quality and regulatory professionals looking to elevate product design and usability.

Learn more and register here: https://tinyurl.com/mrwx7ps5

01/26/2026

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

01/26/2026

AAMI is offering a 3-day Design Control course!

We’ll cover design control requirements under FDA Quality System Regulation, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP).

📅 When: Three full days (9:00am–6:00pm EST) February 11-13, 2026
🎓 With: Experts from industry and the FDA who take part in the entire course

You’ll learn to:

Check if your design control system meets FDA and ISO requirements

Spot gaps or issues in your process

Make the improvements needed to stay compliant

If you’re in regulatory affairs, quality, engineering, manufacturing, or R&D, this course will help you build confidence and skill in managing design control requirements.

👉 Learn more and register here: https://tinyurl.com/2s35ms4m

01/23/2026

Registration & Housing for AAMI eXchange 2026 are NOW OPEN!

AAMI members can receive more than $200 off registration!

We’ve also partnered with Resiada by Streampoint as the official eXchange 2026 housing partner! We have several great hotels, all walking distance from the Colorado Convention Center.

To register: https://tinyurl.com/44rk6fzb

For housing details: https://tinyurl.com/5cbkez8b

Questions? Contact us at eXchange@aami.org

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01/23/2026

AAMI neXus 2026 is just a few months away! Don't miss this opportunity to share your perspectives and thought leadership with an audience eager to learn from your experience and vision.

Engage in discussions driven by innovation and collaboration, shaping the future of medical device development and compliance. Tracks include:

-Regulatory & Standards

-Digital & Advanced Technology

-Sterilization

-The Interface of Humans & Technology

Check back here for more session announcements and all things neXus! To learn more, visit: https://tinyurl.com/y9xr548n

We look forward to welcoming you April 14-17 in Leesburg!

News Feed FiltersAll Updates This Month This Week Open search filters Search Search Feed… Reset Show all updates All updates by new posts New posts Recent activity EVENT Peyton posted a new event 2 months ago 2 months ago Quality Systems Foundation (Jan26) Comprising 8-hours spread out over two da...