Use of Exaggerated Surface Area to Solution Volume Ratios in Extractables Studies; Equilibrium Case
The goal of this whitepaper is to provide comprehensive guidance and justify appropriate practices concerning the proper...
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When Drug Meets Device
When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility...
Why Extractables and Leachables Matter
Medicines and other healthcare products rely on a delicate balance between quality, safety, and efficacy for their...
DISINFECTION VALIDATION: How to Classify and Validate Your Medical Device Disinfection Process
Reprocessing reusable medical devices involves cleaning, disinfecting, and sterilizing them to ensure they are safe and effective...
Considerations for Third-Party Reprocessing of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by a third-party reprocessor offers significant benefits for healthcare...
EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7
Sterilizing medical devices via ethylene oxide (EO) gas is an effective and widely used practice within the...
How to Evaluate a New Product Against an Existing Product in a Validated EO Process
Section 12 of ISO 11135:2014 provides a pathway for adding new or modified ("candidate") products to an...
Medical Device Extractable and Leachables Testing in 2020
The world of physics is grounded in beautiful universal constants that seamlessly integrate into the equations governing...
Benefits of Premarket and Postmarket Particulate Testing of Cardiovascular Devices
Incorporating particulate testing into the development plans of medical devices, particularly cardiovascular devices, is crucial for ensuring...
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...