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...
Browse Content
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...
Single Use Endoscopes Critical Safety and Regulatoy Considerations for Manufacturers
The transmission of infections via endoscopy remains a critical concern due to the inherent design challenges of...
Implementing Parametric Release for EO Sterilization
Join us for an informative webinar that reviews the benefits of parametric release and how to establish...
The Impact of Sterilization Modality on Connected Devices with Electronic Components
devices. The complex nature of connected devices, which often involve a combination of materials and electronic components, can...
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...