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


Institut Straumann AG ISO 13485 Manufacturing sites included

TÜV Süd Product Services GmbH
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

Institut Straumann AG ISO 13485 CMDCAS Canada

TÜV Süd America Inc.
07.11.2017 PDF, 888 KB Download

Straumann Villeret SA ISO 14001

Swiss TS Technical Services SA
25.04.2016 PDF, 287 KB Download