MADE IN ITALY
Passion For Innovation
CERTIFIED PROCESSES AND DETAILED CONTROL
Quality and safety are imperatives for our products. Continuous analysing and reducing risk to zero for malfunction, contamination and breakage maintains our high standard of quality. We optimize our production by making use of advanced design, production and control systems eliminating the possibility of defects or errors.
All medical devices manufactured by D-Heart carries a CE marking in accordance with Directive 93/42/EEC. The accurate monitoring of the production process via advanced computer systems provides complete and continuous traceability of our devices. Our complete respect for quality is the best guarantee of reliability.
Management System
ISO 9001:2015
EN ISO 13485:2016
www.bureauveritas.com
ID:
ISO 9001:2015 Quality certification confirms D-Heart drive towards formalizing and implementing procedures to ensure high quality standards and continuous improvement while gathering customer feedback and suggestions.
Management System
ISO 9001:2015
EN ISO 13485:2016
www.bureauveritas.com
ID:
ISO 13485:2016 Certification dictates the regulatory requirements for quality management systems that enable organisations to demonstrate its ability to provide medical devices and related services.
CE 1370 certification per directive 93/42/EEC, modified by directive 2007/47/EC.
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