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.