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

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

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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

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

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

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(CSA) approach for Production, Process and Quality System Software (PPQS) that is detailed in the expected proposed FDA Draft Guidance.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

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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Expert Insights

The Benefits of Creating an ISO 13485 Based QMS for HTM Professionals

In 2022, Norton Healthcare Corporation's (NHC) Clinical Engineering group achieved the distinction of becoming the first in-house medical device service organization to achieve ISO 13485 accreditation. This milestone was driven by their commitment to establishing a robust Quality Management System (QMS) and aligning with Norton Healthcare Corporate's pursuit of ISO 9001-based accreditation by DNV.
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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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Upcoming Events

Expert Insights

Medical Device Cybersecurity 101 for HTM Professionals (Oct 2023)

Oct 10 to Oct 12, 2023

Expert Insights

Risk-Based Computer Software Assurance Approach for PPQS (November 2023)

Nov 28 to Nov 30, 2023

Expert Insights

Acceptance Sampling Plans - Cutting Through the Jungle (December 2023)

Dec 13 to Dec 14, 2023

Expert Insights

Key Updates: AAMI TIR45:2023 - Guidance on Agile Practices (January 2024)

Jan 10 to Jan 19, 2024

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