This case study looks at remediating biocompatibility workflows to meet EU MDR compliance requirements. CLIN-r+ supported the manufacturer with their problematic biocompatibility workflows to address audit findings and deficiencies and pass the second NB assessment.
Remediating biocompatibility workflows to meet EU MDR compliance requirements Read More »
The Toxicological Risk Assessment and Biological Evaluation documentation will undergo significant modifications with the release of the much awaited revisions in this area. Clin-r+ highlights the changes made in 2023 to toxicology and biological evaluation that manufacturers need to be aware of, and what it means for the documentation required to be compliant.
Toxicological Risk Assessment and Biological Evaluation Read More »
What is biocompatibility for a medical device?
Why is it needed? What does it do?
We have all the answers and more…
Biocompatibility and how to apply extractables and leachables to medical devices. ISO 10993 now requires knowledge of any chemicals released by a device while it is in use. This is now included in the testing matrix for each device category. Although materials characterisation isn’t the only way to get this information, it’s the most likely way to discover unexpected materials.
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