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 are scientifically validated and, in case of a medical device class IIa or higher, certified by a Notified Body.
ORTEC Logiqcare B.V. is a pioneering firm that seamlessly merges mathematics, software technology and scientific research to innovate healthcare