Our Certifications

Geratherm Respiratory GmbH manufactures and CE marks its products according to the latest regulations, e.g. EU 2017/745 (Medical Device Regulation, MDR) and Directive 2011/65/EU (RoHS). The quality management system complies with DIN EN ISO 13485, the risk management with DIN EN ISO 14971. Medical devices adhere to applicable parts of the DIN EN ISO 60601 series and the ATS/ERS Guidelines. All relevant technical standards and medical guidelines are followed.

Geratherm Respiratory GmbH is working with SLG Prüf- und Zertifizierungs GmbH, 09232 Hartmannsdorf, Germany (Notified Body 0494).