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.
Certificate EN ISO 13485
Harmonized norm that includes requirements for quality management and for the QM systems of medical device manufacturers.
Certificate EN ISO 9001
Norm that includes industry-neutral requirements for quality management and the QM systems of manufacturers.
Certificate MDD
Most important instrument for the verification of safety and medical-technical performance of medical devices in the European Economic Area.
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.
BEGO Medical GmbH
Certificate EN ISO 13485
Harmonized norm that includes requirements for quality management and for the QM systems of medical device manufacturers.
Certificate EN ISO 9001
Norm that includes industry-neutral requirements for quality management and the QM systems of manufacturers.
BEGO Implant Systems GmbH & Co. KG
Certificate MDSAP
Common standard for regulatory quality management audits of medical device manufacturers recognized by several countries.
Certificate EN ISO 13485
Harmonized norm that includes requirements for quality management and for the QM systems of medical device manufacturers
Certificate MDD
Most important instrument for the verification of safety and medical-technical performance of medical devices in the European Economic Area.
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.