Validated Reprocessing Services for Reusable Medical Devices

Manufacturers face increasing regulatory scrutiny regarding the reprocessing of reusable medical devices. Ensuring that cleaning, disinfection, and sterilisation instructions are both effective and safe is a prerequisite for market access.

At SAXOCON, we bridge the gap between complex regulatory requirements and practical validation. We ensure your Instructions for Use (IFU) are backed by robust data, protecting both patient safety and your brand reputation.

Comprehensive Validation Support

We provide a turnkey solution that helps you plan, execute, and document reprocessing validation studies, including:

• Material Compatibility:
  Selecting construction materials that withstand repeated cycles of heat and chemical exposure.
• Regulatory Alignment:
  Ensuring full compliance with international standards, including AAMI TIR12, ISO 17664, and ISO 17665.
• Laboratory Coordination:
  Selecting the right CROs and expert monitoring of validation studies to ensure data integrity.
• Safety Assessments:
  Evaluating the removal of pathogenic microorganisms and assessing potential toxicity from cleaning agent residues.

Why Choose SAXOCON?

SAXOCON navigates the intersection of microbiology and toxicology and provides:

• Multidisciplinary Expertise:
  Direct access to a senior team of microbiologists, toxicologists, and material scientists.
• Independent Third-Party Strategy:
  We provide unbiased, state-of-the-art evaluations that carry weight with notified bodies and regulatory authorities.
• Risk Mitigation:
  We identify potential failures in your device’s construction or function before they become costly regulatory hurdles.

Delivery

We don’t just provide raw data. SAXOCON delivers a concise, audit-ready Expert Statement that synthesizes all validation findings and recommendations, providing a clear path to regulatory approval.