ISO 10993-6 2026 Revision: Local Effects After Implantation
Published: June 24, 2026
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Impact on MDR & IVDR Technical Documentation: Targeted Simplification Under COM(2025) 1023
Published: June 17, 2026
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ISO 10993-7:2026 Is Here — What Does It Mean for Your Device?
Published: June 3, 2026
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The FDA’s Recognition of ISO 10993-1:2025: What Does it Mean?
Published: May 27, 2026
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Navigating MDCG 2025‑9: A Practical Guide for Manufacturers Developing Breakthrough Devices
Published: May 27, 2026
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FDA QMSR: What Medical Device Manufacturers Need to Know
Published: April 15, 2026
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The TEMPO Pilot Program: Key Strategic Guidance for Digital Health Manufacturers
Published: February 18, 2026
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FDA Real-World Evidence: What Does It Really Mean and How Does It Work?
Published: January 22, 2026
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How the CER Connects with PSUR, PMCF, and SSCP
Published: January 7, 2026
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MDR: Aspirations vs. Reality in Notified Body Practice
Published: December 17, 2025
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ISO 10993-1:2025 Updates —Top 10 Biological Evaluation Essentials in the Revision
Published: September 12, 2025
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Creating a Biological Evaluation Plan Your Notified Body Will Appreciate
Published: September 3, 2025
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Biological Testing Methods of Medical Devices
Published: July 29, 2025
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Medical Device Packaging: Shelf-Life Validation & Testing Overview
Published: July 21, 2025
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Nanomaterials in Medical Devices: Important Biocompatibility Considerations
Published: June 30, 2025
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What is the Purpose of the Ames Test for Measuring Medical Device Genotoxicity?
Published: June 24, 2025
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