AAMI

Navigate FDA expectations regarding successful submissions, inspections, recalls, problem-solving, and risk avoidance for medical device radiation sterilization.

Radiation Sterilization for Medical Devices
October 15-18, 2024

Participants will learn how to integrate industry standards with the U.S. Quality System Regulation, auditing processes for contract laboratories and sterilizers, and radiation sterilization processing best practices, including safety precautions, characteristics, constraints, and the impact of radiation operations.

This course is highly interactive between faculty and participants. It will include relevant real-life examples and “hands-on” exercises from various medical device products.

Register now:

https://www.aami.org/training/training-suites/sterilization/radiation-sterilization-for-medical-devices

Take advantage of this opportunity to advance your auditing career!

Join us to improve your medical device auditing skills from August 12th to 13th, 2024.

Learn ISO 13485 and 19011 requirements, share auditing best practices, and gain hands-on experience with remote audits. Stay informed about the latest MDR status and work with Notified Bodies.

Materials provided include standard copies, exam records, and post-course community access!

Register now:

https://www.aami.org/training/training-suites/regulatory/lead-auditor

Join our fourth CPS Maturity Journey webinar: 'Fine Tuning Your Cybersecurity Platform: Integration Into the Ecosystem.'

Explore the critical integration of medical device cybersecurity solutions with existing tools like vulnerability risk management, endpoint detection, network security, and more.

Uncover how these integrations enhance the quality of data used by Clinical Engineers/HTM to drive operations.

Tune in to fine-tune your organization's cybersecurity approach for optimal performance and resilience.

Register today to join us on August 13 from 2-3 pm ET.

https://www.aami.org/training/training-suites/healthcare-technology-management-htm/fine-tuning-your-cybersecurity-platform-integration-into-the-ecosystem

Stay ahead of current and emerging cyber threats by enrolling in our Expert Insights course on SW96:2023!

Understanding ANSI/AAMI SW96:2023 – Security Risk Management Guidance
📅 July 30 - Aug 1 | 1:00 PM - 3:00 PM | Three 2-hour Sessions

Gain valuable insights from expert-led lectures that utilize US FDA-recognized publications like AAMI SW96, TIR57, and TIR97, allowing you to fully comprehend the importance and distinctiveness of security risk management throughout the premarket and post-market phases.

Learn more here:

https://www.aami.org/training/training-suites/expert-insights-from-aami-training/understanding-ansi---aami-sw962023-security-risk-management-guidance

Have you thought about how virtual reality can help your HTM department flourish? During the 2024 AAMI eXchange, attendees explored the dynamic landscape of HTM’s evolving relationship with extended reality (XR) technologies.

https://array.aami.org/content/news/transforming-healthcare-technology-management-xr-innovations

Explore the seamless IT security controls and governance extension into the clinical environment, creating a unified defense!

Cyber Synergy: Integrating Health Tech Security Layers
October 15, 2024 | 2:00 pm - 3:00 pm ET | Virtual

Don't miss the culminating chapter of our CPS Maturity Journey: 'Cyber Synergy: Integrating Health Tech Security Layers.'

Witness IT, IoMT, and OT integration to optimize security tools, people, and processes.

This synergy enhances enterprise threat detection, network protection, operational intelligence, and lifecycle management, fortifying the healthcare ecosystem against cyber threats.

Speaker:
Ty Greenhalgh, Industry Principal, Healthcare – Medigate by Claroty

https://www.aami.org/training/training-suites/healthcare-technology-management-htm/cyber-synergy-integrating-health-tech-security-layers

Join our virtual "Industrial Sterilization for Medical Devices" course starting September 23rd!

This comprehensive 4-day program delves into the critical aspects of sterilization technologies, FDA requirements, and essential principles in product design and release decisions.

Our program offers a hands-on approach to learning sterilization processes. You will gain practical knowledge and skills in design, validation, process control, and product release through classroom lectures, situational analyses, and case studies.

This course is for design and process engineers, operations managers, technicians, quality assurance and regulatory compliance personnel, or anyone involved in sterilization processes who is responsible for meeting industry standards and FDA requirements.

Enroll now to elevate your expertise and meet industry standards:

https://www.aami.org/training/training-suites/sterilization/industrial-sterilization-for-medical-devices

Visual inspections are a key part of processing surgical instruments, but sometimes, the human eye isn’t enough. Even when cleaned and sterilized, biological debris sometimes remains on surgical tools – which is why new AI-enabled inspection tools may be the future.

https://array.aami.org/content/news/utilizing-artificial-intelligence-aid-spds-cleaning-verification

Take advantage of the opportunity to enhance your knowledge and skills in process validation!

Register now for our 3-day training on Process Validation Requirements and Industry Practices from August 5-7.

Seats are limited and filling up fast, so secure your spot today!

This course explicitly targets medical device industry professionals, including R&D Team Members, Quality Engineers, Quality Assurance Managers, Design Engineers, Project/Program Managers, and Process Engineers.

Gain practical tools and techniques for process validation requirements per FDA's Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force.

Explore industry best practices and real-life process validation examples to enhance your understanding.

This course is ideal for those with a basic understanding of the Quality System regulation and relevant work experience.

Register now:

https://www.aami.org/training/training-suites/quality-systems/process-validation-requirements-and-industry-practices

In today's healthcare environment, the proper sterilization and reprocessing of reusable medical devices are paramount to preventing infections and ensuring patient safety.

AAMI TIR99:2024 provides essential guidance on the best practices, protocols, and quality control measures for processing probes and dilators.

Join AAMI's training program on Understanding AAMI TIR99:2024 - Ultrasound Probe Processing Guidance on September 9th to equip yourself with the knowledge and skills necessary to ensure the safe and effective processing of dilators, transesophageal and ultrasound probes, by the guidelines set forth by the Association for the Advancement of Medical Instrumentation (AAMI) Technical Information Report (TIR) 99.

https://www.aami.org/training/training-suites/expert-insights-from-aami-training/understanding-aami-tir99-guidance-on-ultrasound-probe-processing

How is generative AI going to change HTM? At the 2024 AAMI eXchange, we heard from Aaron Hanna of NVRT Labs, who discussed what generative AI can actually do and how existing tools may change HTM for the better.

https://array.aami.org/content/news/how-generative-ai-change-htm-aami-exchange

With the rise of Big Data and powerful computing platforms, Machine Learning-based Medical Devices (MLMD) are becoming increasingly common.

Join our Risk Management for Machine-Learned Enabled Devices course on September 4th to gain an unparalleled deep dive into MLMD technology, setting itself apart by covering the distinctions from traditional software development and navigating you through the complex regulatory landscape for MLMD across the globe!

Learn more here:

https://www.aami.org/training/training-suites/expert-insights-from-aami-training/machine-learning-for-medical-devices

The 2024 AAMI eXchange featured a closing keynote from Herman McKenzie of The Joint Commission. Did you miss the conference, or do you have questions about how TJC’s priorities apply to your facility? AAMI News has you covered.

https://array.aami.org/content/news/back-basics-herman-mckenzie-s-keynote-joint-commission

Explore GE HealthCare's New Product!

ReadySee: a single asset management and network monitoring solution

Product Spotlight Highlights:

-Discover all devices communicating on your network, including patient monitors, central stations, and accessories like PDMs and Parameter Modules.
-Quickly identify devices in need of service or updates by type, model, manufacturer, software, or OS versions.
-Improve device management efficiency by tracking the last time a device was seen on the network and viewing if a device is clinically in use.*
-Proactively identify network performance changes and reduce the risk of patient data loss with alerts for network infrastructure and critical traffic flows (i.e., HL7, Vitals).
-Stay ahead of potential security threats by identifying networked device vulnerabilities and detecting suspicious or unauthorized traffic.

*Exclusive for GE HealthCare patient monitors.

Learn more here:

https://www.youtube.com/watch?v=x9vMlpFYhzo

Product Demo:

https://www.gehealthcare.com/services/readysee?utm_source=aami&utm_campaign=USC-PCS-SVC-AAMI-AWR-EM-24-04&utm_medium=sponsored-email

Explore the critical integration of medical device cybersecurity solutions with existing tools like vulnerability risk management, endpoint detection, network security, and more!

Fine Tuning Your Cybersecurity Platform: Integration Into the Ecosystem
August 13, 2024 | 2:00 pm - 3:00 pm ET | Virtual

Join our fourth CPS Maturity Journey webinar: 'Fine Tuning Your Cybersecurity Platform: Integration Into the Ecosystem.' Uncover how these integrations enhance the quality of data used by Clinical Engineers/HTM to drive operations. Tune in to fine-tune your organization's cybersecurity approach for optimal performance and resilience.

Speaker:
Ty Greenhalgh, Industry Principal, Healthcare – Medigate by Claroty

https://www.aami.org/training/training-suites/healthcare-technology-management-htm/fine-tuning-your-cybersecurity-platform-integration-into-the-ecosystem

Risk management during medical device reprocessing is critical. At the AAMI eXchange, Atila Nozari, PhD of Solventum presented on risk management, best practices, and applying AAMI standards to reprocessing.

https://array.aami.org/content/news/risk-management-medical-device-reprocessing

Gain valuable insights from expert-led lectures that utilize US FDA-recognized publications like AAMI SW96, TIR57, and TIR97!

Understanding ANSI/AAMI SW96:2023 – Security Risk Management Guidance
📅 July 30 - Aug 1 | 1:00 PM - 3:00 PM | Three 2-hour Sessions

These lectures will allow you to fully comprehend the importance and distinctiveness of security risk management throughout the premarket and post-market phases.

Speakers:
David Nelson, Associate Software Director, Boston Scientific Neuromodulation
Michael Seeberger, Boston Scientific – Global Product Cybersecurity Group, Product Cybersecurity Manager

Secure your spot here:

https://www.aami.org/training/training-suites/expert-insights-from-aami-training/understanding-ansi---aami-sw962023-security-risk-management-guidance

Join us for AAMI's flagship Quality System Regulation training!

This training allows you to examine your own QMS and determine whether it complies with both Quality System requirements and ISO 13485 requirements, pinpointing where improvements are needed.

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements
Aug 19 - 23, 2024 | 4.5-Day | Virtual

Register now to join us!

https://aami.org/training/training-suites/quality-systems/quality-system-regulation

During the 2024 AAMI eXchange, attendees heard from Crew Weunski, Regulatory Lead at MediView, on the challenges of current 2D imaging technologies and traditional healthcare collaboration methods.

https://array.aami.org/content/news/augmented-reality-surgical-navigation-new-dimensions-diagnostic-imaging

Explore the operationalization of cybersecurity roles for Clinical Engineers and Health Technology Management!

Cybersecurity Adoption: Operationalizing Roles & Responsibilities
September 17th | 2:00 PM - 3:00 PM ET

Dive into critical responsibilities such as vulnerability risk management, device reconciliation, procurement protocols, basic cyber mitigations, utilization management, and seamless coordination with information security and IT.

Learn how to integrate these practices for a robust cybersecurity adoption strategy, ensuring the safety and resilience of healthcare technology.

Speaker:
Ty Greenhalgh

Register today!

https://www.aami.org/training/training-suites/healthcare-technology-management-htm/cybersecurity-adoption-operationalizing-roles-and-responsibilities

Are you ready to implement ANSI/AAMI ST108:2023 at your department?

Join Terra Kremer and Erin Kyle on August 14th for an Expert Insights course designed to familiarize you with the standard.

In this 2-hour session, attendees will learn the importance of maintaining water quality in central processing, the requirements for ensuring water quality during reprocessing reusable , and the indicators of water quality issues.

Register today:

https://www.aami.org/training/training-suites/expert-insights-from-aami-training/navigating-ansi-aamist108-2023-guidelines-for-water-quality

SaMD (Software as a Medical Device) is one of the fastest-growing types of Medical Devices worldwide.

This creates a unique situation where traditional software companies are now becoming Medical Device Manufacturers (MDMs), and traditional MDMs are developing more Software.

Join us for an exclusive webinar to learn what Software qualifies as SaMD and how it can be unique from commercial Software and traditional medical devices. In addition, learn what portions of the QMSR apply to SaMD and what that means for your company.

Mastering SaMD: Navigating Regulations & The Product Lifecycle
Sep 17th - 19th | 1:00 PM - 3:00 PM | Three 2-hour Sessions

Don't miss out—register now to accelerate your journey to SaMD expertise!

https://aami.org/training/training-suites/expert-insights-from-aami-training/mastering-samd-navigating-regulations-and-the-product-lifecycle

Take advantage of this opportunity to advance your auditing career!

Join us August 12th-13th, 2024 to improve your medical device auditing skills.

Learn ISO 13485 and 19011 requirements, share auditing best practices, and gain hands-on experience with remote audits. Stay informed about the latest MDR status and work with Notified Bodies.

Materials provided include standard copies, exam records, and post-course community access!

Register now:

https://www.aami.org/training/training-suites/regulatory/lead-auditor

As medical devices are increasingly moved into patients’ homes, “hospitals without walls” are becoming the norm in healthcare. At AAMI eXchange, we heard from a panel of excerpts on how this will impact HTM professionals and the field overall.

https://array.aami.org/content/news/keynote-presentation-hospitals-without-walls

Accelerate your device approval process with our July Design Control course!

Design Control Requirements - Integrating the Quality System Regulation
📅 July 16 - July 18, 2024 | 3-Day Course | Virtual

Experience comprehensive coverage of design control requirements with active participation from FDA representatives throughout the program for a unique learning experience!

Learn more here:

https://www.aami.org/training/training-suites/quality-systems/design-control-requirements

Should the government regulate medical device servicing? At the 2024 eXchange, AAMI facilitated a debate among several members with different perspectives. Get the recap of their discussion below!

https://array.aami.org/content/news/medical-device-servicing-right-to-repair

Do biomedical technicians have the right guidance on paperwork best practices? After surveying HTM professionals and assessing current guidance, several experts found that they do not, and that new guidance is needed.

https://array.aami.org/content/news/htm-paperwork-speaks-standards-whitepaper-survey

Thank you Crothall Healthcare for sponsoring our exhibit hall Welcome Reception!

Make sure to visit them at booth #832

Learn more at the link below about all of our sponsors and how you can become a sponsor at AAMI eXchange 2025! ⚜️

https://www.aami.org/events/exchange24/sponsors-and-exhibitors