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....
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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...
Disinfectant Efficacy Testing on Site Specific Surfaces
Disinfection efficacy studies play a significant role in the Pharmaceutical manufacturing environment in ensuring that the surfaces...
How to design an Instruction For Use and validations for EU and US
In this free on-demand webinar, Kathleen Peymen, PhD, Senior Expert, takes you on an road trip to discover...
Navigating the FDA’s Medical Device Pre-submission Process
This presentation provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for...
Container Closure Requirements: Preparing for USP
Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the...
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....
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...
Disinfectant Efficacy Testing on Site Specific Surfaces
Disinfection efficacy studies play a significant role in the Pharmaceutical manufacturing environment in ensuring that the surfaces...
Biocompatibility as a Critical Design Input
For any medical device contacting a patient, a biocompatibility evaluation is required before the device can be...
