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Step 12: Approvals

We clear the way. Safely. In the area of development, standards have to be taken into consideration and approvals applied for and granted. We deal with the legal formalities for you. The necessary requirements are already defined in the system specifications and the entire development process is designed in such a way that the necessary criteria are fulfilled.
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Step 12: Approvals Details

We develop our products in accordance with national and international standards, which means that nothing can stop you from attaining your CE marking in Europe. We have dealt with and continue to deal with national approvals for you, such as a model inspection or international approval processes by, for example, the UL, CSA or FDA/510K.

Furthermore, we comply with important quality standards such as ISO 9001 and draw up risk analyses and FMEAs.

In the field of medical technology, we always work in accordance with the following standards: IEC 60601-1 (3rd edition)/Directive 93/42/EEC (new EU Directive 2007/47/EC)/IEC 62304/EN ISO 13485:2003/AC:2009.
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Feo Elektronik GmbH ENG
Zwergerstraße 15
88214 Ravensburg, Germany
Tel. 49(0)751 295 105-20
Fax 49(0)751 295 105-90

Management: Dipl. Ing. David Clus

Registration office: county court of Ulm,
CR 551644
VAT ID NO.: DE 174353404
Person responsible for the content:
David Clus
Design, technical implementation: sons.

In spite of careful content control we accept no liability for the content of external links.

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general terms and conditions (PDF 135 KB)

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