Certificate No. 60153210

Certificate Number: 60153210
Certificate Holder: DRG International., Inc.

841 Mountain Avenue
07081 Springfield
United States

Scope see attachment
Manufacturing and distribution of in vitro diagnostic
reagents used in the diagnosis of autoimmune status,
cancer, cardiac markers, disease status, fertility testing,
pregnancy testing, diabetes and immune status.
Installation and service of in vitro diagnostic analyzers.

Fulfilled Standards: EN ISO 13485:2016
Certificate Type: QMS

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.