Quality standards

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 ISO 13485 CMDCAS Canada

TÜV Süd America Inc.
07.11.2017 PDF, 889 KB Download

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

TÜV Süd Product Services GmbH
03.08.2017 PDF, 396 KB Download

Institut Straumann AG ISO 13485 Manufacturing sites included

TÜV Süd Product Services GmbH
03.08.2017 PDF, 706 KB Download

Straumann Villeret SA ISO 14001

Swiss TS Technical Services SA
25.04.2016 PDF, 284 KB Download

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

TÜV SÜD Product Service GmbH
09.03.2016 PDF, 89 KB Download

Straumann Andover ISO 14001

BSI
11.02.2015 PDF, 460 KB Download

Biora AB - ISO 14001

TÜV NORD CERT GmbH
25.11.2014 PDF, 576 KB Download