04Aug. Date August 4, 2025 Author Sultan CulumHow do the new medical device regulations in Europe affect the development of biomaterials?With the MDR (2017/745) and IVDR (2017/746) regulations, which came into force in 2021, the safety and transparency criteria...
28July Date July 28, 2025 Author Sultan CulumMDCG Guidance 2025 Published: New Criteria for Risk Classification | June 2025The Medical Device Coordination Group (MDCG) and the Artificial Intelligence Board (AIB) have merged...
10July Date July 10, 2025 Author Sultan CulumGenotoxicity, Carcinogenicity, and Reproductive Toxicity According to ISO 10993 | nano-test.deGenotoxicity, Carcinogenicity, and Reproductive Toxicity According to ISO 10993The manufacturing of medical devices is subject to...
02July Date July 2, 2025 Author Sultan CulumHemolysis Test | EN ISO 10993-4Hemolysis Testing for Medical Devices | EN ISO 10993-4The Nanolab Laboratories Group is an accredited laboratory...
30June Date June 30, 2025 Author Sultan CulumIrritation Test for Medical Devices | EN ISO 10993-23The contact of medical devices with the human body carries various biological risks, particularly for products...
27June Date June 27, 2025 Author Sultan CulumSensitization Test for Medical Devices: EN ISO 10993-10Medical devices must comply with high safety and biocompatibility standards, as they come into direct or indirect contact with the...