What does risk-based biocompatibility under the new ISO 10993-1 really look like?
The era of the "checklist" approach to biocompatibility is officially over. With the publication of ISO 10993-1:2018...
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Calculation of the Duration of Exposure and Associated Biological Effects for Biocompatibility Evaluation
In the biocompatibility assessment of medical devices, two of the primary points of consideration are how long...
DAY 1 – Big Changes in Medical Device Biocompatibility: Updates Coming to ISO 10993-1
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
DAY 2 – Big Changes in Medical Device Biocompatibility: Updates to USP Class VI Impacting Medical Device Materials
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
DAY 3 – Big Changes in Medical Device Biocompatibility: How to Address These Updates for Existing Products and In-Process Submissions
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
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...
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...