Focus on Fundamentals: Day 2 – Considerations for Biocompatibility
Biocompatibility assessments involve extensive evaluation, and changing the sterilization modality, such as to VH2O2, can trigger considerable,...
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Biocompatibility as a Critical Design Input
For any medical device contacting a patient, a biocompatibility evaluation is required before the device can be...
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....
Biocompatibility Fundamentals for Medical Devices
This comprehensive eBook serves as an essential guide for professionals involved in the design and manufacture of...
What is Cytotoxicity
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel. Dr....
Intro to Pre-Clinical Testing and Biocompatibility
In this episode of the RCA Podcast, host Brandon Miller is joined by Dr. Matthew Jorgensen and...
Cytotoxicity Failure What Now
Cytotoxicity testing is a critical endpoint for all medical devices that come into contact with patients or...
Cytotoxic Reactivity Understanding the Cause and the Path Forward
All medical devices intended to contact patients must undergo a rigorous biological evaluation to ensure their safety....
Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18
All medical devices that are intended to contact patients or medical personnel (directly or indirectly) require an...
