Documenting Device Changes in Biological Risk Assessments: Part One
“Device changes can range in complexity, making it critical that each change be treated uniquely and assessed...
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Reprocessing Rethought: An Open Forum Discussion On Novel Decontamination Methods for Reusable Medical Devices
As reusable medical devices have advanced, the importance of effective decontamination methods (cleaning, disinfection, and/or sterilization) has...
Regulatory Insights: The Future of MedTech and Pharma Under the New Administration
The new presidential administration in the United States could significantly impact MedTech and pharmaceutical regulations for manufacturers...
Navigating the FDA’s Medical Device Presubmission Process
This webinar provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for...
Updates to ISO-18562:2024 – A CRO Point of View
The 2024 updates to the ISO 18562 series of standards bring quite a few changes. In this...
Unmasking the Unknown: How Mass Spectrometry Delivers Accurate Identifications
In this webinar, presented by our Senior Expert LC/MS, Ruud Cuyvers, you’ll expand your knowledge on unexpected impurities in Drug...
History & Modern Practices for ASTM E1174: Evaluating the Effectiveness of Healthcare Personnel Handwash Formulations
ASTM E1174 was first developed in 1987 and was developed to evaluate Healthcare Personnel Handwash (HCPHW) Formulations...
Focus on Fundamentals: Day 3 – Toxicological Considerations of VH2O2 Sterilization Residuals
VH2O2 sterilization may leave hydrogen peroxide residuals on the device materials after the sterilization process whose toxicological...
Focus on Fundamentals: Day 2 – Considerations for Biocompatibility
Biocompatibility assessments involve extensive evaluation, and changing the sterilization modality, such as to VH2O2, can trigger considerable,...
Focus on Fundamentals: Day 1 – VH2O2, Sterilization Considerations
VH2O2 has been a common sterilization option for reusable devices for many years. Interest has increased for...