Reprocessing Considerations during Design Development for Reusable Medical Devices
Reusable medical devices are medical devices intended for repeated use on patients. These devices range from simple,...
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Sterilization by Filtration: Validating Filtration for an Aseptic Process
This presentation explores the validation of sterilization by filtration as a critical step in aseptic pharmaceutical processing....
A Dive into Disinfection Validations of Non-critical Devices
This discussion swims through topics related to disinfection validations of non-critical devices. Including selecting the appropriate level...
DAY 1 – Big Changes in Medical Device Biocompatibility: Updates Coming to ISO 10993-1
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
DAY 2 – Big Changes in Medical Device Biocompatibility: Updates to USP Class VI Impacting Medical Device Materials
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
DAY 3 – Big Changes in Medical Device Biocompatibility: How to Address These Updates for Existing Products and In-Process Submissions
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
Navigating the Decision Flow: Changing Sterilization Modalities for Medical Devices
As global regulatory pressures tighten and supply chain challenges increase, medical device manufacturers are increasingly considering changes...
Radiation Sterilization: What do product characteristics tell you about the type and source of radiation to use?
Since the installation of the first irradiators for the sterilization of single-use healthcare products in the 1960’s,...
Qualification of Primary Container/Closures for Parenteral and Ophthalmic Drug Products
This webinar provides a high-level introduction to Primary Packaging Qualification in the pharmaceutical industry. We take a...
Reprocessing Rethought: Effective cleaning and sterilization of robotic devices
One of the many advancements in the medical device industry has been the advent of reusable robotic...