Solving Cytotoxicity Challenges with an Absorbent Medical Device

Download our case study to see how Cormica solved a common but critical challenge, without delaying regulatory timelines.

When a novel absorbent medical device failed to yield enough extract volume for cytotoxicity testing, it posed a serious threat: inconclusive data, regulatory delays, and compliance risks. In this case study, discover how Cormica’s team of experts overcame the issue through a tailored and validated approach, ensuring ISO 10993-5 compliance and keeping the client’s development on track.

Why Download This Case Study?

• Real-world solution to an issue many device manufacturers face during biocompatibility testing
• Step-by-step breakdown of how Cormica adapted standard extraction protocols for an absorbent material
• Proven outcome: Valid cytotoxicity results, no submission delays, and full compliance with EU MDR and FDA expectations