Wunder complies with the ISO 9001: 2015 standard which certifies the Design, Production and Assistance of scales for medical and industrial use and the Marketing and Assistance of scales for domestic and industrial use.

Wunder own the CE Approval Certificate of the Production Quality Assurance System as a manufacturer of instruments approved or approved for legal use in relation to third parties in accordance with Directive 2014/31/EU and the European standard EN45501. The metrological marking indicates that the instrument is equipped with a type approval or examination certificate, issued by the European Notified Body, which validates its suitability for legal use.

The HACCP Compliance Verification – Europe (HCV EU) program verifies the hygienic quality of commercial food equipment. With this all-inclusive program, we demonstrate our commitment to food safety and compliance with European standards such as the EC 1935/2004 standard for food in contact with materials and the EN 1672-2 standard for hygienic design.

The ISO 13485: 2016 standard defines the requirements for a quality management system for medical device manufacturers. In quality of manufacturers of medical devices, we offer the guarantee that our products are designed, manufactured and marketed according to the guidelines set by the standard, in order to meet the requirements specific requirements of the market and the relevant laws.

Wunder produces instruments approved for legal use in relation to third parties in compliance with directive 2014/31/EU and the European standard EN45501. Furthermore, to be freely sold within the European Union and EFTA, medical devices must comply with the relevant product directives, and be CE marked. For the CE marking of Medical Devices the EU Directive 93/42/EE and subsequent amendments applies.

As from the D.L. N ° 93 – 21 April 2017, instruments with a legal measurement function must be subjected to a periodic inspection by an authorized laboratory.