Certifications

The development, manufacturing and distribution of medical devices requires a specific company structure that enables the quality and safety of the product to be met in accordance with the regulatory requirements for medical products. The specific requirements for a Quality Management System are specified through the harmonized standard EN ISO 13485:2016.

For this purpose, cosinuss° has defined appropriate internal processes and established an ISO 13485-compliant Quality Management System covering design and development as well as production and distribution of monitoring devices of vital physiological parameters. The Quality Management System is audited regularly by the accredited Notified Body TÜV Süd to proof its functionality according to the harmonized standard EN ISO 13485:2016. The current certificate can be downloaded here: Certificate EN ISO 13485:2016

MDR Quality Management System Certificate

The Medical Device Regulation (MDR) of the European Union is a comprehensive and demanding regulation designed to ensure the safety and performance of medical devices within the EU. An important step for manufacturers to market their medical devices in the European market is the conformity assessment and subsequent certification.

Annex IX of the MDR is a pivotal part of this regulation, outlining specific requirements for the conformity assessment and certification of medical devices. Chapters I and III of Annex IX are of particular significance as they govern the procedures for the conformity assessment and certification of Class IIa and IIb products, as well as certain Class III products.

As part of the conformity assessment for a medical device approval according to Annex IX, Chapters I and III of the MDR, the accredited Notified Body TÜV SÜD reviewed our quality management system and technical documentation. As confirmation of our compliance with the MDR, a certificate has been issued, which is available for download here: EU Quality Management System Certificate MDR

EU Declaration of Conformity

The product cosinuss° Health complies with the essential requirements outlined in Annex I of the MDR (EU) 2017/745. The device is classified as Class IIa according to Annex VIII of the Regulation (EU) 2017/745 on medical devices. EU Declaration of Conformity cosinuss° Health

cosinuss° servers are all located in Germany and approved for medical use in digital and physical security.

All privacy data processed is located within the EU and subject to the highest privacy regulations (GDPR/DSGVO).