Respiratory Care Safety Validation

To secure a CE Mark and maintain market access in the EU, medical devices must be proven safe and effective for their intended use. For devices that provide respiratory care or supply substances via the respiratory tract, the ISO 18562 series dictates a rigorous process for evaluating gas pathway biocompatibility. Ensuring that patients are not exposed to harmful VOCs, particulate matter, or inorganic condensates is critical to both regulatory approval and patient safety.

SAXOCON provides the end-to-end expertise required to plan, test, and document compliance for respiratory devices, including:

• Biological Evaluation Plan (BEP):
  Designing a scientifically justified test strategy tailored to your device.
• Material Characterization:
  Selecting and screening construction materials specifically validated for respiratory use.
• Laboratory Oversight:
  Selecting qualified laboratories, reviewing technical protocols, and monitoring tests per ISO 18562 requirements.
• Regulatory Advocacy:
  Providing expert assistance during scientific advisory meetings with regulatory bodies.
• Toxicological Risk Assessment:
  A data-driven analysis of results to finalize your safety profile.

Why Choose SAXOCON?

Our services for respiratory device manufacturers offer a competitive edge through:

• A Multidisciplinary Team:
  Direct access to expert toxicologists, material scientists, and supply chain professionals.
• Specialized CRO Network:
  Access to a well-established test set-up with leading Contract Research Organizations specifically equipped for gas pathway analysis.
• Regulatory Authority:
  Extensive experience in state-of-the-art safety evaluations that align with international standards and regional guidelines.
• Exclusive Data Insights:
  Safety evaluations informed by non-disclosed information obtained from our global network of material suppliers.
• Commercial Efficiency:
  Smart, cost-effective test strategies that bypass unnecessary delays and accelerate your time-to-market.

Delivery

SAXOCON compiles all necessary evidence into a comprehensive Biological Evaluation Report (BER). This audit-ready documentation provides the technical justification required for product approval and serves as a cornerstone of your technical file.