Certyfikat numer 60148244

Numer Certyfikatu: 60148244
Certyfikowany właściciel: Cardiomatics Sp. z o.o.

ul. Wojciecha Weissa 7/C1
31-339 Kraków
Polska
Zakres:

Design and development, manufacture and servicing
of standalone software for ECG signals analysis.
Consulting and contracted designing, prototyping
and production of electronic medical devices.

Spełnione Standardy: EN ISO 13485:2016
Typ Certyfikatu: QM-System Normenkonf. Medizin

Quality Management System
EN ISO13485 quality management standard for medical devices and related services

The European standard EN ISO 13485 specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that constantly meet customer requirements and applicable legal requirements.

Competent auditors analyze and evaluate the customer's quality management system. If all applicable requirements are met, its quality management system is certified according to EN ISO 13485.

The customer's quality management system is subject to regular monitoring.

Certified customers may use the test mark in their communication.

Further information on this service can be found here.