Certificates

BEGO Quality Management

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.

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Certificate EN ISO 13485

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

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Certificate EN ISO 9001

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

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Certificate MDD

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

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

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 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