Long-Term Biocompatibility and Clinical Safety

To secure a CE Mark for an implantable medical device, manufacturers must provide definitive evidence of safety and performance. Given the long-term contact with host tissue and blood, ISO 10993-1 requires a deep-level evaluation that goes beyond basic testing. Comprehensive physicochemical, morphological, and topographical characterization is essential to understanding how an implant interacts with the biological environment over its lifetime.

SAXOCON provides the specialized expertise required to navigate the high-risk pathway for stents and implants, including:

• Biological Evaluation Plan (BEP): Developing a scientifically robust and justified strategy tailored to long-term invasiveness.
• Strategic Material Selection: Guiding the selection of construction materials to ensure high-performance biocompatibility.
• Advanced Characterization: Coordinating physicochemical, morphological, and topographical testing per ISO/TS 10993-19.
• Laboratory Oversight: Selecting qualified laboratories, reviewing technical protocols, and monitoring biological tests throughout the ISO 10993 series.
• Regulatory Advocacy: Expert representation and support during scientific advisory meetings with regulatory bodies.
• Toxicological Risk Assessment: Final expert analysis of all data to confirm patient safety.

Why Choose SAXOCON?

Our approach to high-risk implantable devices provides:

• Specialized High-Risk Insight: A team of toxicologists and material scientists who specialize in the unique complexities of long-term tissue and blood interaction.
• Proven Regulatory Success: Extensive experience delivering safety evaluations that meet the industry’s most stringent international standards.
• Supplier-Level Transparency: Access to non-disclosed material data from our global supplier network to fill critical gaps in your technical file.
• Commercial Predictability: Smart, cost-effective test strategies designed to satisfy regulators the first time, preventing costly rework and delays.

Delivery

SAXOCON compiles all necessary evidence into a definitive Biological Evaluation Report (BER). This comprehensive document serves as the core of your technical file, providing the rigorous justification needed to achieve and maintain market approval for implantable devices.