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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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...
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...
Biocompatibility Testing: What You Need to Know
When it comes to biocompatibility testing on medical devices, there are many aspects that have to be...
Guidance on Combining Biocompatibility and Cleaning Validation Testing
Testing all biocompatibility endpoints for reusable medical devices both at first-time use and after multiple reprocessing cycles...