Container Closure Requirements: Preparing for USP
Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the...
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Biocompatibility as a Critical Design Input
For any medical device contacting a patient, a biocompatibility evaluation is required before the device can be...
2023 AAMI Biological Evaluation Standards week meetings
Join us for an engaging podcast featuring business leaders from Nelson Labs who have just returned from...
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...
Introduction to Microbiology and Sterilization
Are you looking for foundational knowledge on microbiology as it relates to sterilization services and testing? Watch...
Removing rabbits from irritation testing: Current status of regulatory acceptance of ISO 10993-23
In recent years, significant changes have been made to the standards and practices surrounding biocompatibility testing, driven...
Skin Care Products Understanding Clinical Testing Options
Skin-care products have become an essential part of the cosmetic and personal-care industry. Whether you are dealing...
Is it time to Re-Evaluate your Design History File for Reusable Device Validations
Standards for reprocessing have become a top priority for regulatory bodies worldwide. The active work around reusable...
Guidance on Combining Biocompatibility and Cleaning Validation Testing
Testing all biocompatibility endpoints for reusable medical devices both at first-time use and after multiple reprocessing cycles...