Navigating ISO 10993 Compliance for EU Market Access

To market a medical device in the EU, a CE Mark certificate is mandatory. This certificate serves as the definitive proof that your product is safe and performs as intended. At the heart of this process is the ISO 10993-1:2025 standard, which dictates the requirements for designing, testing, and documenting the biological safety of your device.

SAXOCON provides the end-to-end expertise required to navigate these complexities. We ensure your documentation is robust enough to withstand the scrutiny of Notified Bodies.

Comprehensive Biocompatibility Services

Our team manages the entire lifecycle of biological evaluation, providing:

• Biological Evaluation Plan (BEP):
  A strategic roadmap that describes and justifies your testing methodology based on risk.
• Material Characterization:
  Expert selection, screening, and characterization of construction materials to minimize unforeseen toxicological issues and identify potential risks early in the design phase.
• Regulatory Advocacy:
  Expert representation and technical support during scientific advisory meetings with Notified Bodies and regulatory authorities.
• Laboratory Management:
  Selection of qualified laboratories, protocol review, and monitoring of tests to ensure full compliance with the ISO 10993 series.
• Toxicological Risk Assessment:
  A detailed analysis of results to determine clinical safety.

Why Choose SAXOCON?

• Multidisciplinary Expertise:
  Access to our team of toxicologists, material scientists, and supply chain professionals who understand the nuances of medical device regulation.
• Data-Driven Safety:
  Benefit from safety evaluations powered by proprietary data from our global network of material suppliers, reducing the need for costly, time-consuming in vivo testing.
• Regulatory Precision:
  We apply state-of-the-art safety evaluations that align with both international standards and specific regional guidelines (MDR/IVDR).
• Strategic Efficiency:
  We design smart, cost-effective test strategies focused on one goal: bringing your product to market without regulatory delays.

Delivery

The culmination of our process is a comprehensive Biological Evaluation Report (BER). SAXOCON synthesizes all data, testing results, and expert justifications into a single, submission-ready document designed to secure regulatory approval for your product.