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Quality management

 

 

Our quality management system encompasses the following areas:

Development, manufacture and/or sale of rotary steel, carbide, diamond and ceramic instruments, rotary ceramic abrasives, polishers and brushes, as well as accessories for medical and non-medical use

and is based on the requirements specified by the international standard

Medical Devices - Quality management systems - Requirements for medical purposes ISO 13485:2003 + Cor. 1:2009; German Version EN ISO 13485:2012 + AC:2012.  

 

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Certificate (296KB)

For medical devices placed on the market in the European Union, we also comply with the requirements of the module "Total quality assurance system" in accordance with the Annex II of Directive 93/42/EEC  

(with the exception of section 4).

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Certificate (578KB)

 

On completion of the conformity assessment procedure specified for the products, we are consequently entitled to feature the CE mark on our medical products.
Our continual efforts to maintain the quality system are verified through annual investigations (audits) by an officially accredited, notified body in Germany and certified when confirmed.

 

Our notified body (as stipulated by the EC Directive) 
is entitled, supervised and accredited by the central health

protection office of the German Federal States for pharmaceuticals

and medical devices (ZLG).

In addition, our selected Notified Body is accredited by the

National Accreditation Body for the Federal Republic of Germany

(Deutsche Akkreditierungsstelle GmbH, DAkks).

These accreditations empower our Notified Body to

certify according to the Standard of

EN ISO 13485 and the  European Medical Device

Directive 93/42CEE.

 

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