Made in Italy, Passion for Innovation

CERTIFIED PROCESSES AND DETAILED CONTROL

We focus our attention on the quality and safety of our products, strictly analysing and reducing to zero any risk of malfunction, contamination, breakage with a very high standard of quality. We use advanced systems of design, production and control, to optimize our production, eliminating the possibility of errors or defects.

We certify with the CE marking that all medical devices manufactured by D-Heart, are in accordance with Directive 93/42/EEC. The accurate monitoring of the production process through advanced computer systems ensures complete and continuous traceability of our devices. Our absolute respect of quality is the best guarantee of reliability.

Management System
ISO 9001:2008
EN ISO 13485:2012

www.bureauveritas.com
ID:
ISO 9001 Quality confirms D-Heart orientation towards formalizing procedures to ensure high quality standards and continuous improvement in their efforts while also gathering customer feedback and suggestions.
Management System
ISO 9001:2008
EN ISO 13485:2012

www.bureauveritas.com
ID:
ISO 13485 specifies requirements for quality management systems that enable an organization to demonstrate its ability to provide medical devices and related services that meet the requirements of customers and applicable regulatory requirements.
D-Heart products are CE 1370 certified per Directive 93/42/EEC, which was recently modified by Directive 2007/47/EC and on active diagnostic medical devices with the possibility to transfer within the European Union.

Google Play App Store