Artificial Intelligence and Machine Learning Based Software as a Medical Device
In our first episode, host Erika Porcelli is joined by Lisa Michels, General Counsel and Regulatory Affairs...
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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...
Transportation and Distribution Testing for Medical Devices
An essential yet sometimes overlooked component of packaging shelf life validation is transportation and distribution testing. This...
Biocompatibility: Applying the New ISO 10993 Standards
Biocompatibility is a critical aspect of medical device development, ensuring that devices are safe and do not...
Critical First Steps of an Ethylene Oxide (EO) Validation – Process Definition Process Definition The Critical First Steps in the Validation of an EO Sterilization Process
In this webinar, you will learn about the importance of process definition (fractional) work as a part...
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...
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...