What is a Sterilization Dose Audit and How are they Performed?
The performance of periodic sterilization dose audits is required when a sterilization dose has been established using...
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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...
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...
Choosing Colorants for Medical Devices
Colorants are frequently added to the substrates and material components of medical devices to enhance usability and...
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...
Packaging Design Validation Testing
Manufacturers of medical devices must ensure that their terminally sterilized products are contained within validated packaging to...
An Introduction to Radiation Dosimetry and the Mathmatical Model
This webinar offers an in-depth overview of radiation dosimetry, focusing on essential principles and calibration methods required...
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...
Regulatory Landscape for EO Residue Levels in Medical Devices
The global regulatory landscape around Ethylene Oxide (EO) residues is a topic of increasing interest. This webinar...
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...