Certyfikat numer 60138059

Numer Certyfikatu: 60138059
Certyfikowany właściciel: Minerva Biolabs GmbH

Schkopauer Ring 13
12681 Berlin

Contract development and manufacturing of various molecular
biology, NAAT-based in-vitro diagnostic reagents for
the detection of diseases

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.