Certificati

Gestione della qualità BEGO

BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG

Certificate MDSAP

Common standard for regulatory quality management audits of medical device manufacturers recognized by several countries.

Download


Certificate EN ISO 13485

Harmonized norm that includes requirements for quality management and for the QM systems of medical device manufacturers.

Download


Certificate EN ISO 9001

Norm that includes industry-neutral requirements for quality management and the QM systems of manufacturers.

Download


Certificate MDD

Most important instrument for the verification of safety and medical-technical performance of medical devices in the European Economic Area.

Download


Certificate MDR

The Medical Device Regulation (EU) 2017/745 (MDR) replaces the Medical Device Directive 93/42/EEC (MDD) and regulates the requirements for the placing on the market and surveillance of medical devices in the European Union to ensure the quality and safety of the devices.

Download

BEGO Medical GmbH

Certificate EN ISO 13485

Harmonized norm that includes requirements for quality management and for the QM systems of medical device manufacturers.

Download


Certificate EN ISO 9001

Norm that includes industry-neutral requirements for quality management and the QM systems of manufacturers.

Download

BEGO Implant Systems GmbH & Co. KG

Certificate MDSAP

Common standard for regulatory quality management audits of medical device manufacturers recognized by several countries.

Download


Certificate EN ISO 13485

Harmonized norm that includes requirements for quality management and for the QM systems of medical device manufacturers

Download


Certificate MDR

The Medical Device Regulation (EU) 2017/745 (MDR) replaces the Medical Device Directive 93/42/EEC (MDD) and regulates the requirements for the placing on the market and surveillance of medical devices in the European Union to ensure the quality and safety of the devices.

Download