#medical devices

November Regulatory Updates
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Medical Devices: ISO 10993-1:2025 finally released, 6th edition of the standard on Biological risk evaluation...
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October Regulatory Updates
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Medical Devices: FDA Draft Guidance on Quality Management System Regulation (QMSR) The FDA has published...
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September Regulatory Updates
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Medical Devices: Consultation Open: EU seeks to simplify MDR and IVDR Frameworks The European Commission...
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August Regulatory Updates
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Medical Devices: European Commission Confirms Continued Use of Titanium Dioxide in Medicinal Products Background On...
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Chemsafe’s Summer Reading Recommendations 2025
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With the warmth of the summer sun shining down, there is no better time to...
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July Regulatory Updates
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Medical Devices: MDCG Publishes Position Paper on UDI-DI Timelines for Optical Devices Implementation Deadlines Set...
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EU Update: New Expert Panel for High-Risk Medical Devices
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Decision (EU) 2025/1324 — Published on 7 July 2025 The European Commission has adopted Decision...
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Toxicology in the World of Medical Devices
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Regulation (EU) 2017/745 on medical devices aims to raise the quality and safety standards of...
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May Regulatory Updates
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REACH: EU Member States Approve First-Ever REACH Ban on Entire PFAS Group in Firefighting Foams...
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Updates on ISO 10993-23
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Iso 10093:1-2025 is out! Check out the new standard. On May 1, 2025, the amendment...
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