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AAMI Honors Standards Developers, Committees, and Sterilization Professionals

Please join AAMI in celebrating the 2024 winners of its Standards Developer, Technical Committee, and Sterilization Science awards. These awards will be conferred at the AAMI/FDA neXus on February 21, 2024.

CDRH Director Shuren Opens AAMI/FDA neXus

On February 20, CDRH Director Dr. Jeffrey Shuren opened AAMI/FDA neXus with a keynote on the value of standards, CDRH medical device standards programs like ASCA and TAP, and what industry can expect from FDA in the future.

Why ASCA is Here to Stay, and How it Can Help You

The ASCA program is now permanent, but still voluntary. At AAMI neXus, attendees heard from a trio of FDA experts on how the program can benefit regulators and device sponsors by speeding up and streamlining submission reviews.

AAMI Honors Standards Developers, Committees, and Sterilization Professionals

Please join AAMI in celebrating the 2024 winners of its Standards Developer, Technical Committee, and Sterilization Science awards. These awards will be conferred at the AAMI/FDA neXus on February 21, 2024.

Read More
CDRH Director Shuren Opens AAMI/FDA neXus

On February 20, CDRH Director Dr. Jeffrey Shuren opened AAMI/FDA neXus with a keynote on the value of standards, CDRH medical device standards programs like ASCA and TAP, and what industry can expect from FDA in the future.

Read More
Why ASCA is Here to Stay, and How it Can Help You

The ASCA program is now permanent, but still voluntary. At AAMI neXus, attendees heard from a trio of FDA experts on how the program can benefit regulators and device sponsors by speeding up and streamlining submission reviews.

Read More
"RAQA 4.0" is Now! Artificial Intelligence Can Help

Developing and implementing artificial intelligence for medical devices is hard enough. Navigating the changing rules for regulating these evolving devices is even harder! Fortunately, you may be able to fight fire with fire... For this special column, two regulatory affairs and quality assurance experts explain how professionals can harness AI to keep track of AI-related guidance and communications.

FDA Explains Medical Device Cybersecurity Requirements

“Cyber threats can, have, and very much do pose patient safety risks to the healthcare sector.” FDA’s Jessica Wilkerson assured AAMI/FDA neXus attendees that the agency's new regulatory priorities for medical device cybersecurity do not come from a love of paperwork, but out of concern for patient safety.

FDA Makes the Case for Quality

A voluntary pilot program to help medical device companies foster and promote continuous quality improvement—beyond regulatory compliance—has achieved notable business results. Attendees for AAMI/FDA neXus 2024 were treated with an in-depth pulse check of the FDA's Case for Quality Voluntary Improvement Program.

"RAQA 4.0" is Now! Artificial Intelligence Can Help

Developing and implementing artificial intelligence for medical devices is hard enough. Navigating the changing rules for regulating these evolving devices is even harder! Fortunately, you may be able to fight fire with fire... For this special column, two regulatory affairs and quality assurance experts explain how professionals can harness AI to keep track of AI-related guidance and communications.

Read More
FDA Explains Medical Device Cybersecurity Requirements

“Cyber threats can, have, and very much do pose patient safety risks to the healthcare sector.” FDA’s Jessica Wilkerson assured AAMI/FDA neXus attendees that the agency's new regulatory priorities for medical device cybersecurity do not come from a love of paperwork, but out of concern for patient safety.

Read More
FDA Makes the Case for Quality

A voluntary pilot program to help medical device companies foster and promote continuous quality improvement—beyond regulatory compliance—has achieved notable business results. Attendees for AAMI/FDA neXus 2024 were treated with an in-depth pulse check of the FDA's Case for Quality Voluntary Improvement Program.

Read More
AAMI Accepting 2024 Applications for TMC, HTLC

AAMI is accepting applications for openings on its Technology Management Council (TMC) and its Healthcare Technology Leadership Committee (HTLC). Learn about the requirements and how you can get involved.

FDA and Industry on the Future of Device Maintenance

At the AAMI/FDA neXus, attendees received an update on remanufacturing and maintenance standards, and a timetable regarding future guidance from FDA and AAMI standards development participants.

HTM's Invisible Lead Time: Addressing Leadership Development

With staff shortages a real problem—and an aging population putting pressure on the workforce—many HTM departments have recognized that they need to ramp up internal leadership development. AAMI's Leadership Development Guide was written with overcoming this challenge in mind. AAMI board member Barrett Franklin, FACHE, CCE, explains...

AAMI Accepting 2024 Applications for TMC, HTLC

AAMI is accepting applications for openings on its Technology Management Council (TMC) and its Healthcare Technology Leadership Committee (HTLC). Learn about the requirements and how you can get involved.

Read More
FDA and Industry on the Future of Device Maintenance

At the AAMI/FDA neXus, attendees received an update on remanufacturing and maintenance standards, and a timetable regarding future guidance from FDA and AAMI standards development participants.

Read More
HTM's Invisible Lead Time: Addressing Leadership Development

With staff shortages a real problem—and an aging population putting pressure on the workforce—many HTM departments have recognized that they need to ramp up internal leadership development. AAMI's Leadership Development Guide was written with overcoming this challenge in mind. AAMI board member Barrett Franklin, FACHE, CCE, explains...

Read More
VHP Sterilization and the Rise of 3D Printed Devices

Hospitals are increasingly using 3D printing to manufacture medical devices device parts in house. At AAMI/FDA neXus, Randal Eveland of STERIS explained how this trend can benefit patients and how vaporized hydrogen peroxide sterilization can be used to sterilize these devices.

Top 10 Sterilization News Updates for 2024

2024 is set to be an exciting year for the sterile processing community with new AAMI standards, FDA action, and AAMI stakeholder events all on the way. Read on to get AAMI’s top 10 sterilization stories to watch for 2024!

UMD and Noxilizer: Right Material, Right Modality

The UMD and Noxilizer partnership continues on! During the AAMI/FDA neXus 2024, attendees heard the latest on this partnership, its findings, and about implications for the future of sterile processing and materials compatibility.

VHP Sterilization and the Rise of 3D Printed Devices

Hospitals are increasingly using 3D printing to manufacture medical devices device parts in house. At AAMI/FDA neXus, Randal Eveland of STERIS explained how this trend can benefit patients and how vaporized hydrogen peroxide sterilization can be used to sterilize these devices.

Read More
Top 10 Sterilization News Updates for 2024

2024 is set to be an exciting year for the sterile processing community with new AAMI standards, FDA action, and AAMI stakeholder events all on the way. Read on to get AAMI’s top 10 sterilization stories to watch for 2024!

Read More
UMD and Noxilizer: Right Material, Right Modality

The UMD and Noxilizer partnership continues on! During the AAMI/FDA neXus 2024, attendees heard the latest on this partnership, its findings, and about implications for the future of sterile processing and materials compatibility.

Read More
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