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...
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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...
New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016
Product family grouping, as discussed in Clause 4 of ANSI/AAMI/ISO 11137-2:2013, titled ‘Sterilization of Health Care Products...
Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways in Health Care Application
In March 2017, the new ISO 18562 standard series was released, comprising four parts that address the...
Packaging Design for Sterilization
Bringing a medical device from conception to market involves numerous critical steps, one of which is often...