Company Name Contact Info Location
SZUTEST UYGUNLUK DEĞERLENDİRME A.Ş.
Friedrich-Ebert-Anlage 36, 60325 Frankfurt / / / GERMANY
Contact Info: +49 69 244333026
Hall: 3
Stand: 302A
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Our company was established and started its activities in Istanbul in 2005 when Turkey started negotiations for full membership to the European Union. The Free Movement of Goods, one of the first chapters discussed during the negotiations, became the reason for the establishment of our organization and still remains our main operation area. The purpose of this chapter is to make possible the free movement of industrial products and imported goods from third countries in the internal market by elimination of technical barriers. Achieving this goal requires the application of New Approach Directives and the involvement of Conformity Assessment Bodies. To meet this need in the best way possible, our company started its activities as the full and exclusive representative of Strojirensky Zkusebni Ustav s.p., a Czech notified body in 15 directives. Having acquired its own accreditation and notifications in 2007, SZUTEST is now accredited according to ISO/IEC 17020 as Inspection Body of Type A, ISO/IEC 17065 as Product Certification Body, ISO/IEC 17024 as Personnel Certification Body by TURKAK-Turkish Accreditation Agency and according to ISO/IEC 17021 as System Certification body by TURKAK-Turkish Accreditation Agency and International Accreditation Services-IAS. SZUTEST Laboratories are accredited by TURKAK-Turkish Accreditation Agency and International Accreditation Services-IAS. (TURKAK Accreditation scope can be accessed through https//secure.turkak.org.tr/kapsam/search and IAS Accreditation scope can be accessed through https//www.iasonline.org/search-accredited-organizations-2/) SZUTEST is authorized as Notified Body with number 2195 for performing of CE Marking Conformity Assessment Services in accordance with the relevant directives/regulations of EU Commission. Scope of these services can be accessed through http//ec.europa.eu/growth/tools-databases/nando/ SZUTEST is authorized as Certification Body by Vocational Qualifications Authority of Ministry of Family, Labor and Social Services, Labour Hygiene and Measurement, Test and Analysis Laboratory by Presidency of Institute of Research And Development of Occupational Health And Safety of Ministry of Family, Labor and Social Services, Inspection Body of Type A for Periodic Inspection for Lifts by Ministry of Industry and Technology and International Surveillance Company by Ministry of Trade. Since its establishment, SZUTEST has been assisting Turkish manufacturers with its certification, testing and inspection services and has managed to be one of the most preferred certification and conformity assessment organizations. SZUTEST can provide product conformity assessment services in all countries in the World upon request. Gruop of Companies SZUTEST Konformitätsbewertungsstelle GmbH Scope Conformity Assessment Web www.szutest-germany.de Szutest Ltd Scope Conformity Assessment Web www.szutest.com Malta Conformity Assessment Holding Ltd. Scope Conformity Assessment W

(EU) 2017/745 Medical Device Regulation Certification(EU) 2017/745 Medical Device Regulation Certification
PRODUCT DESCRIPTION:

The CE mark indicates that Medical Devices comply with the provisions specified in the EU s technical regulations and can be placed on the market without entering into free circulation within the EU. SZUTEST Konformitätsbewertungsstelle GmbH has been appointed by the European Commission as a notified body under the Medical Device Directive (EU) 2017/745.

EN ISO 13485:2016 CertificationEN ISO 13485:2016 Certification
PRODUCT DESCRIPTION:

SZUTEST is accredited by TÜRKAK in ISO 13485 Medical Devices Quality Management System Standard certification activities.

TestsTests
PRODUCT DESCRIPTION:

Biomechanical Tests, EN 60601-1 test and Clean Room measurements are the tests and examinations we carry out as accredited.

IQ MEMO Quality Management System SoftwareIQ MEMO Quality Management System Software
PRODUCT DESCRIPTION:

IQMemo has digitized 20 years of quality management experience. Transfer your documents to the digital platform with IQMemo and leave the job of creating, storing and distributing documents to us. Save your institution s memory with us!

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