In this webinar, our Medical Device and ISO expert Dr Rose-Marie Jenvert will tell you more about how you can use in vitro methods for the biological evaluation of medical devices, now offered at our GLP-certified laboratories. She will also introduce you to our expanded medical device offering and how we can help you to comply with MDR.
The webinar will last around 45 minutes, followed by a live Q&A. Even If you cannot attend the live event, make sure to register to get access to the recording.
Attendees will gain insights into:
💡 In vitro biocompatibility testing now in ISO 10993
💡 GARD® compatible with both saline and oil
💡 GARD® for quantitative potency assessment during product development
💡 3Rs strategy in compliance with MDR Rule 21
Highly accurate and ethical alternatives
An exciting evolution is ongoing in the medical device toxicology field, transitioning from a process that largely relied on the results of animal testing to one which is increasingly focused on the use of in vitro methods for the safety assessment of medical device materials. A big step towards replacing animal testing for medical devices was taken when in vitro skin irritation testing using Reconstructed human Epidermis (RhE) tissue was implemented in the ISO 10993-23 standard published earlier this year. Moreover, in vitro assays for skin sensitization have been included in the updated ISO 10993-10.
In vitro biocompatibility package
Our GLP-certified laboratories offer an in vitro biocompatibility package that includes testing of the three endpoints that need to be evaluated for all medical device products: cytotoxicity, skin irritation and skin sensitization, providing a solution for customers looking for a highly accurate and ethical alternative for testing of materials and medical devices.
The endpoint cytotoxicity can be tested in vitro using qualitative and quantitative test methods as described in ISO 10993-5:2009 and have a history of use both for regulatory purposes and as a screening tool early in the product development phase.
The endpoint skin irritation using RhE-tissue according to ISO 10993-23:2021 provides human-relevant results with higher accuracy and fewer false-positive results compared to the rabbit model.
Skin sensitization with GARD®
The endpoint skin sensitization can be assessed in vitro using the GARDskin Medical Device assay, based on a state-of-the-art technology GARD; including human immunological cells, a specific genomic biomarker signature and a machine learning-assisted classification model. The GARDskin Medical Device assay enables the medical device industry to perform in vitro skin sensitization testing of both saline and oil extracts from devices or materials as described in ISO 10993-12 and 10993-10:2021, thus mimicking the intended use of the device when in contact with skin.