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Latest from Our Blog
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FDA’s Partial Recognition of ISO 10993-1:2025 – What to Know and How to Prepare
May 29, 2026FDA’s May 2026 partial recognition of the recently released ISO 10993-1:2025 standard has important implications for medical device manufacturers. Partial…
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Evaluating Genotoxicity under ISO 10993-1:2025 – Key Changes and Challenges
May 27, 2026Genotoxicity refers to a material’s potential to damage genetic material (i.e., DNA) which is important because it can signal a…
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EU MDR Clinical Evaluation Technical Documentation
May 20, 2026Overview For CE marking and throughout the device’s lifecycle, medical device manufacturers must demonstrate conformity with Regulation (EU) 2017/745 (MDR),…
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