Centro de descargas

— Certificados – Gestión de la calidad en BEGO —

El objetivo de BEGO es garantizar constantemente una calidad excelente, la satisfacción del cliente y la eficiencia de los procesos para poder responder de forma rápida y flexible a las exigencias del mercado.

Un sistema de gestión de calidad fiable y certificado nos ayuda a implementar procesos y procedimientos complejos de acuerdo con los requisitos normativos y, como fabricante innovador de productos sanitarios, a ser conscientes de nuestra responsabilidad de dar prioridad a la salud y el bienestar de los pacientes.

Con nuestra amplia gama de certificaciones, garantizamos los más altos estándares de calidad.

BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG

Certificate MDSAP

DEN_BEGO-MDSAP_DE-EN

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

Download

Certificate EN ISO 13485

DEN_BEGO-13485_DE_EN

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

Download

tuv-logo_DEN_EN

Certificate ISO 9001

DEN_BEGO-9001_EN_08-2021

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

Download

tuv-logo_DEN_EN

Certificate MDD

DEN_BEGO-CE_EN

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

Download

Certificate MDR

DEN_MDR_Certificate_DE-EN-2023-09

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

MED_BEGO_13485_EN_01

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

Download

tuv-logo_MED_EN

Certificate ISO 9001

MED_BEGO_9001_EN_01

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

Download

tuv-logo_MED_EN

BEGO Implant Systems GmbH & Co. KG

Certificate MDSAP

IMP_MDSAP_Certificate_EN-2024

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

Download

Certificate EN ISO 13485

IMP_Zertifikat_EN_ISO_13485_2016-DE-EN_EN-2021

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

Download

tuv-logo_IMP_13485_EN

Certificate MDR

IMP_MDR_Certificate_DE-EN

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