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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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...
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...
Biocompatibility Testing: What You Need to Know
When it comes to biocompatibility testing on medical devices, there are many aspects that have to be...
2023 AAMI Biological Evaluation Standards week meetings
Join us for an engaging podcast featuring business leaders from Nelson Labs who have just returned from...
The Biocomp Trail A Challenging hike towards Animal Free Testing
The main purpose of ISO 10993-1 is to emphasize a risk-based approach for evaluating the biocompatibility of...
Overcoming a Cytotoxicity Failure
Every medical device must demonstrate proven biocompatibility to protect users from potential biological risks associated with its...
Biocompatibility Essentials
Biocompatibility is a crucial aspect of medical device design and manufacturing, ensuring that devices do not cause...
What is Irritation and Sensitization
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley to delve...
Current Regulatory Acceptance of Alternative Testing for Biocompatibility
The release of ISO 10993-1 in 2018 marked a significant shift in the biocompatibility evaluation of medical...