2023 AAMI Biological Evaluation Standards week meetings
Join us for an engaging podcast featuring business leaders from Nelson Labs who have just returned from...
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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...
Biocompatibility Fundamentals for Medical Devices
This comprehensive eBook serves as an essential guide for professionals involved in the design and manufacture of...
A Stepwise Approach to Deal with In Vitro Cytotoxicity Failures
Manufacturers are required to perform a biological evaluation of any medical device as outlined in ISO 10993-1....
Biocompatibility of Raw Materials for Medical Devices
Starting with a biocompatible material is crucial for medical device manufacturers. However, regulatory requirements are pushing manufacturers...
How Chemical Characterization Can Supplement and Support Biocompatibility Testing
There’s a lot of urban legend when it comes to using gamma radiation to reduce pathogens in...