Quality standards

We never compromise on quality.

In support of continuously broadening our product offerings, we maintain high quality standards for our operations, products and services. This is key to our strategies concerning sustainable development and sustainable compliance. Our quality policy therefore emphasizes that we continuously innovate and improve our processes in the interest of our customers, patients and stakeholders.

Laws and regulations for medical technology

The implementation of our quality policy is supported by a group-wide quality management system, compliant with laws and regulations in the field of Medical Industry and Straumann’s Dental Solutions, including, but not limited to:

  • EU MDD 93/42/ECC as amended by 2007/47EC
  • US FDA 21CFR 820
  • Japanese PAL
  • Canadian CMDCAS
  • ISO 13485
  • others as applicable

Downloads

Institut Straumann AG EC-Certificate MDD 9342EEC Annex II-4 – Emdogain

DEKRA Certification B.V.
2162627DE02 06.12.2018 PDF, 309 KB Download

Institut Straumann AG EC-Certificate MDD 9342EEC Annex II-4 – BoneCeramic

DEKRA Certification B.V.
2162627DE03 06.12.2018 PDF, 309 KB Download

Institut Straumann AG EC-Certificate MDD 9342EEC G1 Annex II for Regenerative Products

DEKRA Certification B.V.
2162627CE02, 2162627CE04, 2162627CE05, 2162627CE06 06.12.2018 PDF, 3 MB Download

Institut Straumann AG ISO 13485:2016 MDSAP Manufacturing sites included

TÜV SÜD America Inc.
QS6 020326 0061 Rev. 00 05.12.2018 PDF, 3 MB Download

Institut Straumann AG ISO 13485:2016 Manufacturing sites included

TÜV Süd Product Services GmbH
Q5 020326 0059 Rev. 00 23.10.2018 PDF, 1011 KB Download

Institut Straumann AG EC-Certificate MDD 9342EEC G1 Annex II

TÜV Süd Product Services GmbH
22.10.2018 PDF, 627 KB Download

Biora AB - ISO 14001

TÜV NORD CERT GmbH
01.09.2018 PDF, 230 KB Download

Zertifikat

Swiss TS Technical Services SA
25.04.2016 PDF, 208 KB Download

Straumann USA - EMS 525983

BSI
EMS 525983 03.05.2009 PDF, 735 KB Download