Expert regulatory support for medical device approval including MDR and FDA compliance guidance. Provides data-driven safety dossiers and toxicological risk assessments to accelerate time-to-market globally.
Manufactured by
SAXOCON A/S
Virum, Denmark
SAXOCON is a certified toxicological partner. We are a consulting company supporting the medical industry in assuring biological safe product ready to ber certified in the EU and beyond. Our specialists are experts in toxicology, materials science, supply chain management, and quality management systems, with a deep understanding of science and technology, the intricacies of the regulatory process, and how best to work with regulatory bodies around the world. Furthermore, we directly contribute to regulatory development by participating in the committee developing ISO 10993. We are ISO 13485 certified by BSI and founded in 2013. We are partly owned by the Technical University of Denmark (DTU).
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