Updates to ISO 10993-1: Focus on Foreseeable Misuse
There are many updates to ISO 10993-1 a few of which can significantly impact how devices are...
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ISO 10993-1: Key update on the new revision of this critical standard
This webinar delves into the latest updates to ISO 10993-1, the cornerstone standard guiding biocompatibility assessment for...
Documenting Device Changes in Biological Risk Assessments: Part Three
This is the third whitepaper in a four-part series covering different examples of how to document device...
Documenting Device Changes in Biological Risk Assessments: Part Two
This whitepaper, the second in a four-part series covering different examples of device changes to be documented...
Transitioning From Cell-Based Assays to qPCR-Driven Analyses To Ensure Viral Safety in Biologics Manufacturing
The production of biological products in biopharmaceutical manufacturing involves significant risks of viral contamination from human and...
Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety....
Documenting Device Changes in Biological Risk Assessments: Part One
“Device changes can range in complexity, making it critical that each change be treated uniquely and assessed...
Updates to ISO-18562:2024 – A CRO Point of View
The 2024 updates to the ISO 18562 series of standards bring quite a few changes. In this...
Focus on Fundamentals: Day 2 – Considerations for Biocompatibility
Biocompatibility assessments involve extensive evaluation, and changing the sterilization modality, such as to VH2O2, can trigger considerable,...
Handling Unexpected Biocompatibility Test Results in Medical Device Development
Getting unexpected or failing test results for any biocompatibility test can feel like the end of the...