Biocompatibility as a Critical Design Input
For any medical device contacting a patient, a biocompatibility evaluation is required before the device can be...
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What’s New with Reprocessing Validations for Reusable Medical Devices?
There have been many great strides surrounding the guidance for reprocessing (cleaning, disinfection, and/or sterilization) validations for...
Advancing Microbial-Contamination Detection Through Rapid Sterility Testing
Increasing industry and product demand for expedited product release reinforces the need to embrace rapid sterility technologies....
Container Closure Requirements: Preparing for USP
Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the...
The Transfer of Medical Device and Pharmaceutical Products between Radiation Sterilization Modalities
With the growing demand for sterilization of medical devices and pharmaceutical products, the industry is increasingly looking...
2023 AAMI Biological Evaluation Standards week meetings
Join us for an engaging podcast featuring business leaders from Nelson Labs who have just returned from...
GMED- Materials & Packaging for Terminally Sterilized Medical Devices
Join us for an insightful session that covers the essential aspects of packaging, focusing on both basic...
Container Closure Integrity Testing for Pharmaceutical Sterile Barrier Packaging
Container Closure Integrity Testing (CCIT) is crucial for evaluating the sterile barrier integrity of pharmaceutical packaging, including...
Bioburden Testing and Microorganism Characterisization: Enhanced Guidance for Low Sterilization Dose Products
In recent years, concerns have been raised regarding the lack of understanding of bioburden (both numbers and...
2023 Spring AAMI Standards Week Update
In this podcast from Nelson Labs, business leaders who recently returned from the AAMI standards week meetings...