Understanding the EU Medical Device Regulation for Device Companies
The new European Union (EU) Medical Device Regulation (MDR), effective from May 2020, will significantly impact medical...
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Meeting the Requirements of 10.4 of MDR How to Address CMRs
Ensuring compliance with the Medical Device Regulation (MDR) requires a thorough evaluation of medical devices for the...
When Drug Meets Device
When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility...
Navigating upcoming changes in Chemical Characterization according to revised ISO 10993-18
The final draft revision of part 18 of the ISO 10993 series, now titled “Chemical Characterization of...
Biocompatibility and the New MDR
This presentation will provide an in-depth overview of biocompatibility in compliance with the new Medical Device Regulations...
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...
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...
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...