Overcoming a Cytotoxicity Failure
Every medical device must demonstrate proven biocompatibility to protect users from potential biological risks associated with its...
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Biocompatibility Essentials
Biocompatibility is a crucial aspect of medical device design and manufacturing, ensuring that devices do not cause...
Big Changes to ISO 10993 What is happening to the main biocompatibility standard now?
In 2018, TC194, the ISO committee responsible for biocompatibility, released a new version of the 10993-1 standard....
What is Irritation and Sensitization
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley to delve...
Lessons from the Lab
This eBook, created in partnership with Medical Products Outsourcing Magazine, addresses common challenges and best practices for...
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....
Risk Assessment for Single Use Systems: USP 665 vs. BPOG
Disposable plastic components are increasingly popular in biopharmaceutical drug manufacturing systems due to their cost-effectiveness and reduced...
What is Cytotoxicity
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel. Dr....