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ISO Certificate

ISO Certificate
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ISO Certificate

Product catalog summary
Certificate Overview: This document certifies that SOFEMED INTERNATIONAL S.A. has a quality management system that complies with EN ISO 13485:2016 standards. The certificate number is 1154C02200101, originally approved on January 16, 2020, and valid until January 15, 2023.
Scope of Certification: The certification covers the design, manufacture, and sales of non-sterile internal and external fixation orthopedic systems, including intramedullary nails, wires, osteosynthesis plates and screws, external fixators, and thoraco-lumbar fixation devices.
Certification Authority: The assessment was conducted by HTCert Ltd, with George Pappous as the Managing Director and Filippos Kottis as the Certification Director. The certification body is accredited by IAS.
Contact Information: HTCert Ltd is located at Jacovides Tower, 81-83 Grivas Dighenis Avenue, CY-1090, Nicosia, Cyprus. Contact can be made via phone at +357 220 60 771 or email at [email protected].
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Catalog excerpts

ISO Certificate-1

Health Technology CertiFication QUALITY MANAGEMENT SYSTEM CERTIFICATE This is to certify that the quality management system of SOFEMED INTERNATIONALS.A. Km 6 Route de Tunis, B. P. 74, 8027 Soliman 2, Tunisia Issue Date: 16/01/2020 Valid until: 15/01/2023 has been assessed by HTCert and found to comply with Certificate No: 1154C02200101 Original Approval: 16/01/2020 References: W001 1154 01 Design, manufacture and sales of non-sterile internal and external fixation orthopedic systems: intramedullary nails, wires, osteosynthesis plates and screws, external fixators and thoraco-lumbar fixation devices. For and on behalf of HTCert Ltd GEORGE PAPPOUS Managing Director Fl LI PPOS KOTTIS Certification Director ACCREDITED" Management Systems Certification Body JACOVIDES TOWER. 81-83 GRIVAS DIGHENIS AV. CY-1090. NICOSIA. CYPRUS. T: +357 220 60 771. F: +357 220 60 772 [email protected],www.htcert.com

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