Certificados
Gestión de la calidad en BEGO
BEGO´s goal is to constantly ensure excellent quality, customer satisfaction and process efficiency in order to meet the requirements of the market in a quick and flexible way.
A reliable and certified quality management system helps us to implement complex processes and procedures according to the regulatory requirements and, as an innovative medical device manufacturer, to be aware of our responsibility to put the health and well-being of the patients first.
With our extensive range of certifications, we guarantee the highest quality standards.
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 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.