Transportation and Distribution Testing for Medical Devices
An essential yet sometimes overlooked component of packaging shelf life validation is transportation and distribution testing. This...
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Mass Extraction Container Closure “CCIT” for Rigid Containers
Mass extraction is a relatively new method for container closure integrity testing (CCIT) that has been included...
Biocompatibility: Applying the New ISO 10993 Standards
Biocompatibility is a critical aspect of medical device development, ensuring that devices are safe and do not...
Becoming Compliant with the MDRs, A Real Life Case Study
The new Medical Device Regulations (MDRs) became enforceable in May 2022. This significant regulatory shift requires that...
3D Printed Medical Devices and Biocompatibility Whitepaper
The use of three-dimensional (3D) printing techniques to address challenging fabrication problems has become mainstream over the...
Choosing Colorants for Medical Devices
Colorants are frequently added to the substrates and material components of medical devices to enhance usability and...
Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices
3D-printed orthopedic medical devices have gained significant attention due to their potential for enhanced biocompatibility, customizability, and...
Packaging Design Validation Testing
Manufacturers of medical devices must ensure that their terminally sterilized products are contained within validated packaging to...
How to Address Regulatory Change in Your Current Biocompatibility Program
This course is designed to help you stay abreast of the latest changes in regulatory standards, including...
Ethylene Oxide Sterilization, Revision of Annex E, Single Batch Release
ANSI/AAMI/ISO 11135:2014 Annex E has recently undergone significant revisions, expanding the requirements for the release of products...