Eliminating Toxicological Risks Early in R&D

Selecting the right materials is a critical milestone in medical device development. SAXOCON helps manufacturers avoid the high costs of late-stage redesigns by identifying toxicological risks before the design is frozen. We move beyond basic technical specifications to evaluate how materials perform under real-world conditions, sterilization cycles, and long-term environmental exposure, offering:

• Regulatory & Bio-compatibility Alignment:
  We cross-reference all selections against current FDA, EMA, and ISO standards (e.g., ISO 10993) to pre-emptively address compliance hurdles.
• Performance Stress-Testing:
  Evaluation of mechanical properties, chemical resistance, and degradation rates tailored to specific healthcare environments.
• Supply Chain Resilience:
  We select for quality and availability. Our process includes auditing vendors to ensure long-term scalability and cost-stability.
• Documentation:
  A comprehensive Biological Evaluation Plan (BEP) to describe and justify your specific test strategy.

Why Choose SAXOCON?

We act as a specialized extension of your R&D and Regulatory teams, providing the expert oversight required to navigate complex biocompatibility standards, including:

• ERT-Certified Insight:
  Our European Registered Toxicologists provide the authoritative assessments and signatures that Notified Bodies expect.

• Reduced Testing Costs:
  We prioritize computational modelling and existing data to minimize the need for expensive in vivo animal testing.

• Predictive Compliance:
  We evaluate materials against the latest regulatory updates, ensuring your product remains compliant throughout its lifecycle.

• Confidential Data Handling:
  We facilitate the secure exchange of proprietary information with your suppliers, ensuring full characterization without compromising their trade secrets.

Delivery

SAXOCON provides an audit-ready package for your Technical File, including Material Risk Profiles to flag showstoppers, a Biological Evaluation Plan (BEP) for your testing roadmap, and formal Toxicological Assessments for regulatory submission.