Expert Insights
Expert Insights
Lean Six Sigma Core Concepts for HTM Professionals (November 2024)
Nov 4 to Nov 20, 2024
Expert Insights
Pre/Post Market QMS Considerations for AI/ML-Enabled Medical Devices (Nov 2024)
Nov 12 to Nov 12, 2024
Expert Insights
Statistical Process Control (SPC) Charts - A World Class Tool (Nov 2024)
Nov 13 to Nov 13, 2024
Expert Insights
The Essential Elements of HFE in the Product Development Process (Nov 2024)
Nov 14 to Nov 14, 2024
Expert Insights
Diagnostic AI Testing Best Practices for Regulatory Submissions (Nov 2024)
Nov 18 to Nov 18, 2024
Expert Insights
Mastering HTM Accreditation Compliance: Stress Less, Achieve More (Dec 2024)
Dec 3 to Dec 5, 2024
Expert Insights
Understanding ANSI/AAMI SW96:2023 - Security Risk Management Guidance (Dec 2024)
Dec 10 to Dec 12, 2024
Expert Insights
Mastering SaMD: Navigating Regulations & The Product Lifecycle (Jan 2025)
Jan 21 to Jan 23, 2025
Sterilization
Navigating ANSI/AAMI ST108:2023 - Guidance for Water Quality (Feb 2025)
Feb 19 to Feb 19, 2025
Featured Courses
Expert Insights
Chemical Characterization of Medical Devices Workshop
Expert Insights
Diagnostic AI Testing Best Practices for Regulatory Submissions
This course explores testing strategies and study design considerations for diagnostic AI models requiring premarket clearance by regulatory bodies like the USA FDA, EU MDR, and those adhering to ISO 13485 standards. Focusing on detection AI, the training covers bench and clinical testing, emphasizing their roles in bias mitigation, clinical effectiveness, and regulatory compliance.
Expert Insights
Pre Post Market QMS Considerations for AI-ML-Enabled Medical Devices
This course offers a comprehensive overview of Quality Management System (QMS) considerations essential for the development and regulatory approval of diagnostic AI models classified as medical devices. It is specifically tailored for AI models requiring premarket clearance by the U.S. FDA, EU MDR, and other regulatory bodies that mandate adherence to ISO 13485 standards.
Expert Insights
TIR101 How Do IV Smart Pumps Really Work Only the Patient Knows
This webinar features an insightful discussion between a technical specialist, Bob, and a clinical specialist, Jeannine, focusing on the various factors that influence the accuracy of infusion pumps. The session will highlight the importance of the new TIR101 testing, which provides crucial data to help healthcare professionals make informed decisions at the bedside.
Expert Insights
The Essential Elements of Human Factors Engineering in the Product Development Process
This course offers a concise overview of Human Factors (HF) in medical device design, focusing on its integration across all stages of product development, from concept to post-market surveillance (PMS).
Expert Insights
Statistical Process Control SPC Charts - A World Class Tool
Have you ever accused your associates of over-reacting to the slightest changes in production, corrective actions, complaint monitoring, or servicing? Or worse yet, have folks in your organization over-looked obvious trends in those key areas? This webinar will provide a valid statistical procedure that is so simple, you won’t even know that you are applying statistics -- all the time. Statistical Process Control (SPC) charts are highly graphical tools applied in world-class organizations.
Expert Insights
Strategic Design & Implementation of a Cost of Poor Quality Program
Hidden costs from poor quality can significantly impact your company's profitability. Our specialized training program is designed to uncover and address the Cost of Poor Quality (COPQ), which encompasses all financial losses due to product defects and service failures, including scrap, rework, repair, and warranty claims. This course will help you understand how COPQ affects your profit margins and how to communicate these impacts effectively to management.
Expert Insights
Risk Management for Machine Learned Enabled Devices
Machine learning systems can fail in unusual and unexpected ways, when compared to traditional software products. This course will highlight those differences and will also provide a snapshot of the current standards and regulatory landscape associated with the risk of machine learning enabled medical devices.
Expert Insights
Reprocessing for Medical Devices
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.
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.
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.
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.
Expert Insights
Machine Learning for Medical Devices
Expert Insights
Key Updates AAMI TIR162023 - Microbial Factors for EO Sterilization
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.
Expert Insights
Understanding ANSI - AAMI SW962023 – Security Risk Management Guidance
Expert Insights
Radiology Equipment Servicing 101 for HTM Professionals
Expert Insights
FMEA Without Tears
Expert Insights
Lean Six Sigma Core Concepts for HTM Professionals (March 2024)
Industrial Sterilization
Navigating ANSI/AAMI ST108:2023 - Guidance for Water Quality
Expert Insights
Key Updates: AAMI TIR45:2023 - Guidance on Agile Practices
Expert Insights
Validation of Analytical Procedures - Made Easy
Expert Insights
Acceptance Sampling Plans - Cutting Through the Jungle
Expert Insights
Risk-Based Computer Software Assurance Approach for PPQS
Expert Insights
Medical Device Cybersecurity 101 for HTM Professionals
Expert Insights
Test Method Validation: Tools and Methods to Meet FDA Requirements
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.