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QMSR: Understanding Part 820.10 “Requirements for a Quality Management System” and the “Applicable Regulatory Requirements” 7 hours ago
With the FDA’s new Quality Management System Regulation (QMSR) taking effect February 2, 2026, AAMI faculty breaks down Part 820.10—explaining what “applicable regulatory requirements” really mean, how ISO 13485 fits in, and what manufacturers must do to stay compliant.
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Ira Lapides, longtime supporter and AAMI Foundation Board member, shares how the Foundation’s scholarships and research grants elevate the HTM profession—building awareness, legitimacy, and opportunity for the next generation of healthcare technology leaders.
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Longtime AAMI leader and Foundation supporter Marcy Petrini, Emeritus Professor of Medicine, reflects on her decades of service to AAMI and the Foundation. From Board Chair to scholarship advocate, Petrini shares why supporting education and standards is vital to advancing healthcare technology.
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Sterile Processing Week – A Note of Appreciation from AAMI a week ago
This Sterile Processing Week, AAMI would like to express its heartfelt gratitude to the entire sterile processing community.
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Not being a party pooper but this technician should be wearimg eye protection accortding to OSHA and AAMi standards 🙂
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In Memoriam: Jim Piepenbrink – Wit, Wisdom, and Heart a week ago
AAMI remembers Celebrating James “Jim” Piepenbrink—HTM pioneer, longtime BMC clinical engineering leader, and AAMI thought partner. A champion of clinical alarms, standards, and mentorship, Jim advanced patient safety with heart and humor.
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ST79 Revision Process Now Underway a week ago
The revision process for ANSI/AAMI ST79 is currently underway at AAMI. Garland Grisby spoke with Mary Ann Drosnock of Healthmark about the process and what this means for you.
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In Memoriam: Charlie Hancock “The Godfather of Sterilization” a week ago
AAMI and the sterilization community mourn the passing of Charles Oren Hancock. Charlie made three decades of contributions to the science and practice of sterilization.
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A legend and person that i learned a lot from. Condolences to his family and other friends
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Podcasting About Safety, Sticky Notes, and AI, AAMI’s New HTM Show Covers Everything “Basement to Bedside” a week ago
Basement to Bedside is a new quarterly news podcast from AAMI focused on the HTM field. In it, we cover the biggest trends in the field and interview the BMETs and biomedical engineers who work on medical devices and bring optimal patient care from the basement of the hospital to each patient’s bedside. Join us for the inaugural episode!
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‘Bearded Biomed University’ to Offer Free HTM CEUs a week ago
Chace Torres, the Bearded Biomed, and AAMI have a new collaboration. Select episodes of the Bearded Biomed Podcast will be made eligible for free CEUs for your HTM certifications. Find out more!
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Bayer Deepens Commitment to Medical Device Standards Through AAMI Membership a week ago
Andrew Wingen, Director of Regulatory Policy at Bayer Corporation, joined us at the 2025 AAMI eXchange to discuss the company’s efforts to advance innovation in the service of their patients, and how Bayer is getting involved in standards development. A warm welcome to Bayer, one of AAMI’s new members!
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Transporting Sterile Medical Devices? There’s New Guidance for That a week ago
It’s time to think twice about loading that sterile device into your minivan. AAMI TIR109:2025 offers essential guidance for the safe external transport of processed medical devices. Guest author Susan Klacik highlights best practices, regulatory considerations, and quality controls to protect patients, staff, and equipment integrity across…
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AAMI Acquisition of Dental Fix Summit Bridges HTM Gaps a week ago
For the first time, dental equipment management will take center stage at AAMI eXchange 2026 in Denver. AAMI has acquired the popular Dental Fix Summit in order to launch a new Dental Pavilion on the eXchange expo hall floor. This effort bridges gaps in training, awareness, and support for the professionals repairing dental devices.
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QMSR: What You Need to Know about Global Harmonization of Medical Device Regulations a week ago
Guest authors Margaret Koga Ward and Mike Ziemelis break down the FDA’s new Quality Management System Regulation (QMSR), effective February 3, 2026. Discover how it aligns with ISO 13485, new compliance challenges, and key steps to prepare your organization now.
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