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.

Ever wish practical guidance on FDA and ISO 13485 requirements came with a side of tropical paradise? Join us in Costa R...
06/17/2026

Ever wish practical guidance on FDA and ISO 13485 requirements came with a side of tropical paradise?



Join us in Costa Rica this August 25–27 for Design and Development: Navigating and Implementing the QMSR Regulations.



This intensive three-day training provides practical guidance on FDA design control requirements, ISO 13485, MDSAP expectations, and the transition to QMSR.



AAMI Faculty Dave Nelson will walk you through how to evaluate compliance, identify gaps, and strengthen design control systems across the product lifecycle.



Take advantage of $1000 in savings before seats fill up: https://tinyurl.com/2fmfx7dz



06/17/2026

ISO/TC 84 met today in the AAMI Center for Excellence before the 34th Plenary!

ISO/TC 84/WG 3 (Needle-based injection systems - Injector, container and pen needle) discussed revisions to:

ISO ISO/TR 19244, Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters

ISO 11608-1, Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems.

Here's Chairperson Michael Roe of Kaleo, Inc. with details.

Stay ahead of evolving regulatory requirements with training designed to strengthen quality systems, compliance programs...
06/17/2026

Stay ahead of evolving regulatory requirements with training designed to strengthen quality systems, compliance programs, and global market readiness... with some great offerings from AAMI this August!

📅 The Quality Management System Regulation (QMSR) | August 17–21, 2026

Gain a comprehensive understanding of FDA's QMSR, ISO 13485, MDSAP, risk management integration, and global quality system expectations.

🔗 Register: https://tinyurl.com/3chmc2w9

📅 Global Labeling Requirements for Medical Devices Workshop | August 26, 2026

Examine ISO 15223-1, ISO 20417, EU MDR labeling requirements, multilingual labeling considerations, and global compliance strategies. Faculty: Roger Peterson

🔗 Register: https://tinyurl.com/3chmc2w9

📅 Quality Systems Foundation | September 15 & 17, 2026

Perfect for professionals new to quality systems or looking for a refresher on QMS fundamentals, risk management, validation, and QMSR requirements. Faculty: Margaret Koga Ward

🔗 Register: https://tinyurl.com/45cmnmst

06/17/2026

Infections from contaminated endoscopes or duodenoscopes can be hard to track and lethal.

But new research on endoscope processing may provide a way for sterile processing professionals to deal with biofilm buildup in the SPD.

Daniel Lightfoot of Nanosonics joins Below the Hospital host Garland Grisby to discuss research that he recently presented at HSPA 2026, and his findings on a better way to tackle the cyclical buildup of biofilm.

Listen to the full conversation: https://www.youtube.com/watch?v=iL_9icoFGZs

AAMI's Summer Skill Surge Challenge turns professional development into a reason to celebrate and WIN! Our suite of summ...
06/16/2026

AAMI's Summer Skill Surge Challenge turns professional development into a reason to celebrate and WIN!



Our suite of summer courses give you the tools you need to leap your career forward this fall! We'll get you ready for when things get busy.



Register for any course and you are automatically entered to win a weekly drawing for exclusive AAMI summer swag! We'll announce winners on our socials each week starting 6/26.



Check out these upcoming trainings to get you started: https://tinyurl.com/5bsw5pm5



🌎 Medical device labeling requirements are evolving. Are you ready?Join AAMI's Global Labeling Requirements for Medical ...
06/16/2026

🌎 Medical device labeling requirements are evolving. Are you ready?

Join AAMI's Global Labeling Requirements for Medical Devices Workshop on August 26, 2026 for a practical look at the regulations, standards, and implementation challenges shaping global labeling compliance. Taught by Roger Peterson, MSc of Arthrex!

You'll explore key requirements from ISO 15223-1, ISO 20417, EU MDR, and FDA guidance, with a focus on medical device symbols, multilingual labeling, implant cards, patient information materials, and global market readiness.

🔗 Register: https://tinyurl.com/3chmc2w9

As healthcare technologies become more advanced, professionals need the skills to evaluate usability, maintain accountab...
06/15/2026

As healthcare technologies become more advanced, professionals need the skills to evaluate usability, maintain accountability, and safely integrate AI into clinical environments.

Check out our upcoming trainings to stay ahead:

📅 Human Factors for Medical Devices | June 30–July 2, 2026

Learn how human factors engineering supports safer device design, effective usability testing, and successful regulatory submissions. Faculty: Ebony Ayres Whaley, Rita Lin, and Tim Zhang.

🔗 Register: https://tinyurl.com/45w9t639

📅 Human Factors Foundation | July 29–30, 2026

Build a strong foundation in human factors principles, use-related risk, usability testing, and HE75 design concepts. Faculty: MaryBeth Privitera,

🔗 Register: https://tinyurl.com/2hjzpzz2

📅 Human Factors for Medical Devices | September 16–18, 2026

Take a deeper dive into user research, task analysis, risk mitigation, and FDA expectations for medical device usability. Faculty: Edmond Israelski, Farinaz Beniesfahany, Melissa R. Lemke and Samuel Suen.

🔗 Register: https://tinyurl.com/48wayy3m

And more exciting trainings from our AI Governance series, taught by Val Malika Reagon, DrPH, MPH, MLA!

📅 Human–AI Teamwork in Healthcare Technology Environments | June 24, 2026

Explore how AI influences workflows, decision-making, documentation, and accountability in HTM environments.

🔗 Register: https://tinyurl.com/yeefh3ep

📅 Evaluating AI-Enabled Health Technologies for Safety and Performance | September 23, 2026

Learn practical approaches for evaluating AI systems throughout their lifecycle, from validation and monitoring to audit readiness and incident response.

🔗 Register: https://tinyurl.com/325crtje

From foundational QMS concepts to advanced design controls and combination product strategy, these upcoming AAMI trainin...
06/12/2026

From foundational QMS concepts to advanced design controls and combination product strategy, these upcoming AAMI trainings are designed to help medical device professionals navigate evolving regulatory expectations with confidence.

Here are some summer and fall trainings we're excited to offer:

🔹 Quality Systems Foundation — July 21–22, 2026

Build a practical understanding of FDA QMSR requirements and ISO 13485 fundamentals, including risk management, validation activities, and management responsibility within a compliant quality system. https://tinyurl.com/4p2dcfm8

Led by Margaret Koga Ward.

📆 Looking ahead

🔹 Combination Products: A Risk-Based Approach — September 9–16, 2026

Explore FDA and EU approaches to combination product regulation, including cGMP expectations, integrated development, risk management, human factors, SaMD integration, post-market considerations, and inspection readiness. https://tinyurl.com/3ab9kf6w

Led by James Wabby, and Susan Neadle.

🔹 Design and Development – Navigating and Implementing the QMSR Regulations — September 9–11, 2026

Take a deep dive into design controls across FDA QSR/QMSR, ISO 13485, and MDSAP through interactive exercises, real-world case studies, and implementation strategies. https://tinyurl.com/3zxu69fe

Led by Lindsey Howard and Mike Ziemelis.

🔹 Establishing and Sustaining a Robust Medical Device QMS: Guidance from AAMI EQ56 — September 9 & 11, 2026

Learn how to strengthen your Medical Equipment Management Program (MEMP) using practical quality system principles grounded in AAMI EQ56 and aligned with broader regulatory expectations. https://tinyurl.com/3dvaz7fj

Led by Herman McKenzie.

👉 Explore all AAMI training opportunities: https://www.aami.org/aami-training/public-training/

🧪 Chemical characterization plays a critical role in demonstrating medical device biocompatibility and meeting global re...
06/11/2026

🧪 Chemical characterization plays a critical role in demonstrating medical device biocompatibility and meeting global regulatory expectations.

Join AAMI’s Chemical Characterization for Medical Devices Workshop on October 12–15, 2026!

Learn how to apply ISO 10993-17 and ISO 10993-18 requirements, understand extractables and leachables (E&L), and evaluate the impact of materials and manufacturing processes on device safety.

Gain practical insight into analytical chemistry techniques, toxicological risk assessments, and strategies for addressing unknown or low-data chemicals through real-world examples and case studies.

Ideal for regulatory, quality, engineering, laboratory, and biological safety professionals looking to strengthen their understanding of chemical characterization and biocompatibility assessments.

Register: https://tinyurl.com/vjvu98vb

06/11/2026

The public comment period for TIR119, which provides guidance on how to implement ANSI/AAMI ST108, is coming soon!



Here's Terra Kremer of Johnson & Johnson, winner of the 2026 AAMI Sterilization Science Award, with an update. Stay tuned for more ways to get involved!



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