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Expert Insights

AAMI Expert Insights are interactive, virtual presentations from leading industry experts on topics critical to your success. New Expert Insights are being developed every month—check back often to find the latest offerings!

Featured Courses

Expert Insights

Reprocessing for Medical Devices

This course provides a comprehensive overview of the cleaning, disinfection, and sterilization validation of medical devices requiring those processes before clinical use to ensure patient safety.
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Expert Insights

Transitioning to the FDA Quality Management System Regulation (QMSR)

The FDA recognizes the benefits of harmonization with other regulatory authorities, and it has determined that ISO 13485:2016, the globally recognized standard for a medical device organization’s QMS, is substantially similar to the current version of 21 CFR Part 820 which became effective in 1996.

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Expert Insights

Understanding ANSI - AAMI SW962023 – Security Risk Management Guidance

The creation and integration of security risk management processes into an existing medical device manufacturer’s quality management system is a difficult task.  This training will provide the framework for the required engineers and managers across differing domains to plan and execute this update. 
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Expert Insights

Navigating ANSI/AAMIST108:2023 Guidelines for Water Quality

This educational training session aims to familiarize participants with the newly established standard ANSI/AAMI ST108:2023, Water for the processing of medical devices.
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Expert Insights

Mastering SaMD: Navigating Regulations & The Product Lifecycle

SaMD (Software as a Medical Device) is one of the fastest growing types of Medical Devices in the world.  This is creating a unique situation where traditional software companies are now becoming Medical Device Manufactures (MDMs) and traditional MDMs are developing more and more software.  


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Expert Insights

Key Updates: AAMI ST58:2024 – Guidance for Chemical Sterilization

Join us as we go over all the major updates regarding processing (gaseous sterilization, liquid chemical sterilization, and high-level disinfectants) for reusable medical devices. The current version of AAMI ST58 was due for revision, as it was last updated in 2013. These updates will improve safety for personnel performing the processing and enhance patient outcome and experiences with the newly revised guidance.

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Expert Insights

Machine Learning for Medical Devices

With the rise in Big Data and increased horsepower of computing platforms, there is a surge in the development of Machine Learning-based Medical Devices (MLMD.) As with any new technology, there are many benefits, risks, and challenges in the safe and effective development and adoption of MLMD. 
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Expert Insights

Risk-Based Computer Software Assurance Approach for PPQS

AAMI is presenting a 2-part webinar on the Risk-Based Computer Software Assurance (CSA) approach for Production, Process and Quality System Software (PPQS) that is detailed in the expected proposed FDA Draft Guidance. This part lecture / part interactive webinar will help you leverage critical thinking to greatly reduce the effort and cost of software validation.

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Expert Insights

Understanding AAMI TIR99 – Guidance on Ultrasound Probe Processing

This training program is designed to equip healthcare professionals with the knowledge and skills necessary to ensure the safe and effective processing of dilators, transesophageal and ultrasound probes, in accordance with the guidelines set forth by the Association for the Advancement of Medical Instrumentation (AAMI) Technical Information Report (TIR) 99.

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Regulatory

Key Updates - AAMI TIR48 - 2024 – QMS Recommendations for Combo Products

AAMI TIR48:2024, “Quality Management Systems (QMS) Recommendations on Application of the U.S.FDA's CGMP Final Rule on Combination Products,” has been updated to reflect the evolution in regulations and guidance for applying the US FDA cGMP Final Rule on Combination Products.


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Expert Insights

Key Updates AAMI TIR162023 - Microbial Factors for EO Sterilization

In response to the growing emphasis on sustainable EO sterilization practices, this course navigates the evolving landscape by exploring alternative validation methods beyond the traditional half cycle overkill approach.
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Expert Insights

Navigating AAMI TIR106:2024 – Understanding Product Bioburden Data

This educational training session aims to familiarize participants with the newly established AAMI Technical Information Report (TIR), AAMI TIR106:2023, Microbiological methods — Understanding and Use of Product Bioburden Data. 

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Expert Insights

Radiology Equipment Servicing 101 for HTM Professionals

This is a comprehensive training program for individuals seeking expertise in radiology equipment repair. Radiology plays a crucial role in modern healthcare, and maintaining the functionality of digital radiological equipment is vital for accurate diagnosis of a variety of ailments, injuries, and overall patient care.
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Expert Insights

FMEA Without Tears

There are many books, articles, and standards published on Failure Mode & Effects Analysis (FMEA). Unfortunately, when professionals in the field are asked about their experiences with FMEA, they often talk about the pain and suffering involved in the application. So, should we abandon this risk analysis tool because it is just too hard to use or too easy to misuse? 
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Expert Insights

Acceptance Sampling Plans - Cutting Through the Jungle

To the casual observer, Acceptance Sampling Plans can be incredible complex and hard to apply. Worse yet, the subject is a jungle with non-intuitive jargon and crazy acronyms. So why bother? 
The key advantage is that Sampling Plans can save time, money and resources. It certainly answers the question: “How much is enough?”
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Expert Insights

Key Updates: AAMI TIR45:2023 - Guidance on Agile Practices

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Expert Insights

Mastering HTM Accreditation Compliance: Stress Less, Achieve More

This comprehensive training is specifically designed for HTM leaders, equipping them with the knowledge and strategies needed to achieve regulatory compliance in healthcare technology management (HTM). It covers relevant regulatory agencies, their expectations, and effective strategies for meeting or exceeding compliance standards. By implementing proven strategies, HTM leaders can drive continuous survey readiness, reduce stress levels, and minimize unnecessary work for themselves and their teams.
A significant focus of the training is on alternate equipment management (AEM), a critical aspect of HTM. Participants will gain insights into the specific AEM criteria that regulatory agencies evaluate and receive practical guidance on implementing and documenting AEM effectively. This knowledge empowers HTM leaders to manage alternate equipment, minimize disruptions, and ensure readiness in case of equipment failures or emergencies.
The training aims to empower HTM leaders with the tools and insights necessary to succeed in regulatory compliance. By participating, HTM leaders will gain a thorough understanding of regulatory agencies, their expectations, and effective strategies for achieving and surpassing compliance standards. They will also gain valuable insights into AEM, enabling them to effectively manage alternate equipment and maintain a state of readiness.
The goal of this training is to support HTM leaders in navigating the complexities of regulatory compliance successfully, ultimately enhancing their role in ensuring the safety and reliability of healthcare technology systems.
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Expert Insights

Validation of Analytical Procedures - Made Easy

Suppose you have a complex piece of laboratory equipment, or you are manufacturing a diagnostic medical device. A critical question is: “How do you know that you can trust measurements from those instruments?”  This course will provide a working knowledge of Validation of Analytical Procedures. This very valuable statistical methodology is essential for laboratories and certain diagnostic medical devices. 
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Expert Insights

Medical Device Cybersecurity 101 for HTM Professionals

While advancements in medical technology in recent years have led to great improvements in healthcare delivery, those same technology advancements are also creating new cybersecurity risks that, if not properly mitigated, could produce disastrous effects for healthcare organizations and their patients.  
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Test Method Validation - AAMI Expert Insights

Expert Insights

Test Method Validation: Tools and Methods to Meet FDA Requirements

Test Method Validation (TMV) is not only an FDA regulatory requirement, but also key to quality and financial success for a firm. After applying TMV, a firm saved $40 million. Another firm lost a $1 billion contract because they consistently shipped defective product – and the solution was easy using TMV. It all boils down to: How do you know that you have quality if you cannot measure? 

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Upcoming Events

Expert Insights

Transitioning to the FDA Quality Management System Regulation (QMSR) (Aug 2024)

Aug 27 to Aug 29, 2024

Expert Insights

Risk Management for Machine Learned Enabled Devices (Sep 2024)

Sep 4 to Sep 4, 2024

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