ORTEC Logiqcare B.V. complies with all applicable laws and regulations, including the Medical Device Regulation (covering ISO13485, ISO62304, ISO14971), the ICH E6 Good Clinical Practice (GCP), EU Annex 11, General Data Protection Regulation (GDPR) and information security standards (ISO 27001, NEN7510, NEN7513). By using LogiqSuite or CE marked Clinical Decision Support Systems (CDSS), researchers respectively physicians are enabled to comply with these laws and regulations. Our CCDS arescientifically validated and, in case of a medical device class IIaor higher,certified by a Notified Body.
ORTEC LogiqcareB.V. is a pioneering firm that seamlessly merges mathematics, software technology and scientific research to innovate healthcare