MEDETECHNI / QUALITY AND COMPLIANCE
Engineering with standards.
Quality, safety and compliance as part of the development of our medical technology.
IEC 60601
Medical electrical safetyBasic safety and essential performance of medical electrical equipment.
Request documentationCE
European conformity markingConformity documentation for the European medical-device framework.
Request documentationFDA
United States regulatory frameworkRegulatory supporting documentation for medical devices in the United States.
Request documentationExplore the scientific evidence.
Studies, findings and original sources for an informed evaluation.