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.

01/13/2026

Looking to deepen your expertise in radiation sterilization for medical devices?

Join AAMI’s Radiation Sterilization for Medical Devices course. It’s a virtual, 3.5-day training running February 23–26, 2026.

Learn directly from industry experts how to align your sterilization processes with FDA expectations and the ANSI/AAMI/ISO 11137 series radiation sterilization standards.

💡 You’ll learn how to:

🧪 Apply scientific principles of radiation sterilization effectively

📘 Integrate industry standards with FDA Quality System requirements

⚙️ Audit and manage contract labs and sterilization vendors confidently

🚀 Avoid risks and recalls through sound process control and validation

Ideal for design and process engineers, manufacturing leaders and R&D professionals with a working knowledge of sterilization principles.

👉 Learn more and register here: https://tinyurl.com/htrf5eem

01/13/2026

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

01/12/2026

Working with ISO 10993 and extractables & leachables data?

Join AAMI’s Chemical Characterization for Medical Devices Workshop, delivered March 2–5, 2026, via Zoom from 12:00–4:00 PM ET.

This in-depth, practical course covers ISO 10993-17 and -18, global regulatory expectations, and best practices for chemical characterization and biocompatibility assessment.

You’ll learn how to:

🧪 Navigate E&L studies and analytical methods

📘 Apply ISO 10993 standards with confidence

⚖️ Evaluate toxicological risk without animal testing

Ideal for QA/RA professionals, engineers, chemists, toxicologists, and biological safety specialists involved in biocompatibility decisions.

Led by Amir Rahimi, PhD, DABT, this workshop blends science, regulation, and real-world application.

Learn more and register here: https://tinyurl.com/57xhnpmm

01/08/2026

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.

💡 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.

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

AAMI Cybersecurity Visionary Award, sponsored by MedCrypt, honors the industry’s greatest cybersecurity problem-solvers....
01/08/2026

AAMI Cybersecurity Visionary Award, sponsored by MedCrypt, honors the industry’s greatest cybersecurity problem-solvers. Do you or a colleague fit the bill?

Eligible contributions include developing security standards, guidance,
and best practices that strengthen medical device cybersecurity.

Both self-nominations and nominations by others are welcome via the nomination form until JANUARY 15: https://www.surveymonkey.com/r/CVA2026

01/06/2026

Join AAMI’s Integrating Risk Management into the Product Life Cycle course — 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.

This course is tailored to 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 Foundation’s Robert L. Morris Humanitarian Award honors those using health tech to improve global human conditi...
01/06/2026

The AAMI Foundation’s Robert L. Morris Humanitarian Award honors those using health tech to improve global human conditions... and it could be yours!

Eligible nominees apply technology to underserved communities, demonstrating
measurable improvements in access, safety, or patient outcomes.

If you our someone you know is transforming lives through healthcare technology,
submit here by January 15:
https://www.surveymonkey.com/r/RLMH2026

AAMI is offering a Joint Commission Regulation Changes HTMA collaborative January 8th! We’ll help you identify what’s c...
01/05/2026

AAMI is offering a Joint Commission Regulation Changes HTMA collaborative January 8th!

We’ll help you identify what’s changed, what hasn’t, and how that translates to your program.

It’s presented by Samantha (Sam) Jacques, PhD, FACHE, AAMIF, FACCE, Vice President of Clinical Engineering at McLaren Health.

If you oversee clinical engineering, regulatory readiness, or quality, this is a must-attend update for 2026.

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

01/05/2026

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.

💡 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

01/02/2026

We’re 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 how 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

___________________________________________________________________

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

This New Year, AAMI’s hitting the ground running. We’ve got AAMI neXus in April and eXchange in May, two major opportuni...
01/01/2026

This New Year, AAMI’s hitting the ground running.

We’ve got AAMI neXus in April and eXchange in May, two major opportunities to build great things with us. https://aami.org/events/

The AAMI awards nomination deadline is coming up on January 15th. https://aami.org/awards/aami-awards/

We’re also offering another slate of intensive trainings for you and your staff. https://aami.org/public-training/

Watch here and at aami.org for the latest in health tech standards. Happy New Year!

A holiday message from AAMI President & CEO Pamela Arora!
12/24/2025

A holiday message from AAMI President & CEO Pamela Arora!

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