Quality System Audit Succeeded
28/06/2019 | Group of Companies SANED
June 25, 2019 in the production unit of the SANED group of companies - LLC TRONITEK successfully passed the first inspection audit of the quality management system for compliance with the European standard ISO 13485: 2016. The audit was conducted by a certified German company Medical Device Certification GmbH, with which the Ural manufacturer of small medical equipment has been cooperating for more than 10 years.
The audit was carried out in the design department, quality management department, in the procurement department, in warehouses and at all stages of production. The work of the company's departments and all the submitted documentation met the requirements of the auditors and did not cause any serious remarks. As a result, TRONITEK has once again proved that its production and manufactured products comply with the European standard ISO 13 485: 2016 and the European Medical Device Directive 93/42 / ЕЕС.
Recall that the certificate for compliance with the European standard ISO 13485: 2016 and Directive 93/42 / EEC, confirmed by LLC TRONITEC on June 25, 2019, makes it possible to manufacture products that can be sold throughout the European Community. In addition, European certificates give the right to promote products in other countries, such as the Philippines, India, and can also facilitate obtaining permission to sell medical equipment in other countries, for example, in Australia or Southeast Asia.