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Tested quality provides safety for processors and patients

For us as a manufacturer of components for medical products made in Germany, conscientious quality management for our own products is simply a matter of course.

Conformity Declaration

Skin Tolerability Certificate of the Institute Fresenius

SG test mark “Schadstoffgeprüft”

SG plus test mark

DIN EN ISO 9001 Certificate (quality management System)

DIN EN ISO 14001 Certificate (environmental management system)

 

Statutory requirements

The German Medical Products Law (MPG) is in force since 1998 and governs the following requirements for orthopaedic aids such as individual inserts and custom-made orthopaedic shoes:

  • Toxicology: Materials causing allergic reactions of the skin may not be used.
  • Carcinogenity: Carcinogenic materials may not be used.

nora® products comply fully with these statutory requirements. This compliance is confirmed by a declaration of conformity.

Further measures

Over and above the statutory requirements, we have had the nora® products certified by several independent and approved test institutes. nora® products are certified by regular tests carried out by renowned test institutes and may bear the following quality seals:

  • skin tolerability certificate of the Institute Fresenius
  • SG test mark “Schadstoffgeprüft”
  • SG plus test mark

A prerequisite for the use of the above mentioned quality seals is a continuous production monitoring by a quality management system.

Skin Tolerability Certificate of the Institute Fresenius

Since 1988, skin compatibility for skin-coloured nora® products has been confirmed by the Fresenius Institute in regular and comprehensive tests and studies. These products bear the Fresenius seal of approval ”Geprüfte Hautverträglichkeit” (“Tested quality compatible with the skin”).

Regular inspections by Fresenius guarantee maximum safety.

Fresenius

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SG test mark “Schadstoffgeprüft”

This pollutant test mark for our industry is granted by various approved test institutes on the basis of intensive material analyses. The SG package acknowledges not only the analysis of legally prescribed parameters but also e.g. that no carcinogenic amines were detected. Numerous nora® products are tested and certified in line with the SG list of criteria.

SG test mark

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SG plus test mark

Products used by orthopaedic shoe engineers and orthopaedic technicians to make medical products must conform to these statutory requirements. The SG plus Seal of Approval enhances and develops the requirements of the long-standing SG seal to include microbial and physical testing as well as inspection of our production facilities.

Extension of the eco-label ‘Schadstoffgeprüft (SG)’ by:

  • Your asset of quality: Tested wear behaviour and stability of nora® products through dynamic long-term stress tests.
  • Your asset of hygiene: Proven disinfectability of contaminated foot beddings and inserts made of nora® materials.
  • Your asset of safety: Apart from the materials, the production sites as well as the production processes of nora® products in Weinheim are regularly examined and certified.
SG plus test mark

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Further quality tests

And finally, the in-house quality assurance measures taken are supplemented by checks performed by the Freudenberg Forschungsdienste KG, which is an independent laboratory accredited and certified pursuant to DIN EN ISO 9001. Thus, chemical-physical tests are regularly performed e.g. on raw materials and finished products.

Freudenberg Forschungsdienste KG

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