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Featured Courses
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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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Machine Learning for Medical Devices
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Risk-Based Computer Software Assurance Approach for PPQS
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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.
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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Key Updates AAMI TIR162023 - Microbial Factors for EO Sterilization
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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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Radiology Equipment Servicing 101 for HTM Professionals
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Understanding ANSI - AAMI SW962023 – Security Risk Management Guidance
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FMEA Without Tears
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Navigating ANSI/AAMIST108:2023 Guidelines for Water Quality
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Acceptance Sampling Plans - Cutting Through the Jungle
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Key Updates: AAMI TIR45:2023 - Guidance on Agile Practices
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Mastering HTM Accreditation Compliance: Stress Less, Achieve More
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Validation of Analytical Procedures - Made Easy
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Medical Device Cybersecurity 101 for HTM Professionals
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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?
Healthcare Technology Management
The Benefits of Creating an ISO 13485 Based QMS for HTM Professionals
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Lean Six Sigma Core Concepts for HTM Professionals (March 2024)
Upcoming Events
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Medical Device Cybersecurity 101 for HTM Professionals (April 2024)
Apr 23 to Apr 25, 2024