Certifications

Quality management system

Since 1996 the Company is certified UNI EN ISO 9001.

Quality is an  essential  instrument for the production of electro-medical devices, products that need high evolved technological reliability.

In 2008 NUOVA BN has also obtained the Certification UNI EN ISO 13485:2004

1994

- CE marking conformity according to 93/42/CEE Directive

1998

- Obtaining Certification according to UNI EN ISO 9001:1994

2003

- Maintaining Certification according to UNI EN ISO 9001:2000

2008

- Maintaining Certification according to UNI EN ISO 9001:2000
- Maintaining Certification according to UNI EN ISO 13485:2004

2017

- Obtaining Certification: UNI EN ISO 9001:2008 and UNI EN ISO 13485:2012

2018

- Conformity New Regulation Medical Devices (2017/745) MDR UE Regulation
- Conformity Regulation PED 2014/68/UE
- Certificates Module B+D TUV SUD CE 0948
- Obtaining Certification: UNI EN ISO 9001:2015 and UNI EN ISO 13485:2016
- Maintaining Certification according to UNI EN ISO 9001:2000

2019

- Conformity Regulation Medical Devices 93/42 CEE attached II Authority MTIC CE 0068

2020

- Maintaining Certification according to UNI EN ISO 9001:2015
- Maintaining Certification according to UNI EN ISO 13485:2016

Certificate ISO9001:2015
Certificate ISO13485:2016
Certificazione PED 0948
Certificate CE0068 DM MITC