Biological evaluation is a fundamental element in demonstrating the safety of medical devices and compliance with Regulation (EU) 2017/745 (MDR). The ISO 10993 series represents the internationally recognized standard for assessing the biocompatibility of materials and devices throughout their entire lifecycle. Read more in our latest article: https://lnkd.in/ehFbZKGV Want to learn more about Kiwa’s services in the medical industry? Visit our dedicated showcase page for more insights 👉 https://lnkd.in/dFiDkbZ2 #Testing #ISO10993 #RiskManagement #MedicalDevices #MDR
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The title says it all: ISO 10993 is a risk management process, not a testing checklist. What I see too often in practice: manufacturers think in tests first and ask questions later. A solid biological evaluation starts with material characterization and a proper risk analysis. That is where you actually learn something about your product.