Certyfikat numer 60145541

Numer Certyfikatu: 60145541
Certyfikowany właściciel: BMV Bender Medical Vertrieb GmbH

Gewerbegebiet Bitzen 23
53804 Much
Niemcy
Zakres:

see attachment
Design and development, production and distribution of
laryngectomized and tracheotomized patients as well as
surgical instruments, rehabilitation devices for
wound drainage systems and their accessory devices
additional site included:
- BMV Bender Medical Vertrieb GmbH
Unterstr. 9
06493 Harzgerode
Germany
Activity: Production of class I medical devices
(non-sterile, without measuring function)

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.