The latest edition of ISO 10993-1 reinforces the integration of biological evaluation with risk management, introduces updated approaches to exposure assessment, strengthens expectations for material and chemical characterization, and reorganizes biological effect endpoints across the standard.
Overall, evaluations will become more risk-driven, chemistry-focused, and justification-intensive, potentially requiring reassessment of legacy devices. These updates may affect your current biological evaluations and technical documentation.
To support you, we can perform a comprehensive gap analysis of your current biological evaluation against the new ISO 10993‑1 requirements.
Our experts can help you:
• Identify gaps in your existing documentation and processes
• Understand what the updated biological effects tables mean for your device
• Plan the updates needed to stay compliant and audit ready
Contact us to learn how our experts can support you with a smooth transition to ISO 10993‑1:2025. Our team of experts can support you throughout the entire lifecycle of your medical device or in vitro diagnostic device.
