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

DEN_BEGO-MDSAP_DE-EN

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

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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.

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tuv-logo_DEN_EN

Certificate EN ISO 9001

DEN_BEGO-9001_EN_08-2021

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

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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.

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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.

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BEGO Medical GmbH

Certificate EN ISO 13485

MED_BEGO_13485_EN

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

Download

tuv-logo_MED_EN

Certificate EN ISO 9001

MED_BEGO_9001_EN

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.

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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 MDD

IMP_EC-Directive-93-42-EEC-annex-II-DE-EN_EN

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

Download

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