Biological Evaluation of Medical Devices
Biological Evaluations
Master ISO 10993-1 and EU MDR requirements with our end-to-end biological safety road mapping. From initial risk assessment to final documentation, SAXOCON bridges the gaps, clearing your path to a CE Mark. Get your medical device approved quickly and into the hands of patients worldwide.
Reusable Medical Devices
SAXOCON’s bulletproof reusable medical device validation reports ensure your reprocessing safety procedures pass audits. Our AAMI TIR12 and ISO 17665 compliant studies align with non-negotiable regulatory requirements. Minimize bottlenecks and secure your reputation with data you can trust.
Materials Screening
Don’t risk your CE mark on material uncertainty. Our screening provides the toxicological data to satisfy EU MDR and ISO 10993-1 requirements. SAXOCON helps you confidently select materials, filter for CMR and endocrine disruptors, and minimize in vivo testing with our high-end computational tools.
Change Management
Ensure market access when making design changes with SAXOCON’s peer-reviewed toxicological data. Our reports withstand rigorous scrutiny from Notified Bodies, helping you stay compliant with ISO 13485 and ISO 14971. Avoid unnecessary stoppages and gain peace of mind with our expert reports.
Device-Drug Safety
Secure market access for your products with our device-drug compatibility testing. We provide everything you need to document safety and satisfy strict regulatory requirements. Ensure seamless device-drug interaction, streamline documentation, and reduce time to market with our expert evaluations.
Breathing Gas Pathways
Accelerate your CE Mark certification process with SAXOCON’s expert breathing gas pathway services. We provide the strategic planning, rigorous testing, and comprehensive documentation necessary to satisfy regulatory requirements. Ensure patient safety and market readiness with data you can trust.
In Vitro Diagnostics
Ensure your in-vitro diagnostic device complies with (EU) 2017/746 (IVDR) Annex I and is fully prepared for CE Mark certification. SAXOCON provides the expert strategic planning and technical documentation you need to satisfy notified bodies, accelerate market launch, and ensure patient safety.
Stent and Implant Safety
Accelerate your CE Mark certification for stents and implants with SAXOCON’s expertise in ISO 10993-1. We provide the strategic risk assessments and technical documentation required to satisfy notified bodies, ensuring your high-risk devices meet every safety standard for a successful launch.