DNV BUSINESS ASSURANCE MANAGEMENT SYSTEM CERTIFICATE

Transcription

1 DNV BUSINESS ASSURANCE MANAGEMENT SYSTEM CERTIFICATE Certificate No AQ-ARG-NA This is to certify that the Management System of: STEELDEC S.A Valparaiso 4100 Parque Ind. Tortuguitas, (1667) Buenos Aires, Argentina has been found to conform to the standard: ISO 9001:2008 This Certificate is valid for the following product or service ranges: Design, development, production and sales of sterile and non sterile dental implants, prosthetic components and instruments for dental use. Initial Certification date: 17 October 2012 This Certificate is valid until: 17 October 2015 Place and date: Høvik, 17 October 2012 for the Accredited Unit: DET NORSKE VERITAS CERTIFICATION AS, NORWAY The audit has been performed under the supervision of Paula Tartaglia Lead Auditor MSYS 002 Eugenie Winger Husebye Management Representative Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. This Certificate has been digitally signed. See for more info HEAD OFFICE. Det Norske Veritas AS, Veritasveien 1, 1322 Hovik, Norway. Tel: Fax:

2 DNV BUSINESS ASSURANCE MANAGEMENT SYSTEM CERTIFICATE Certificate No AQ-ARG-NA This is to certify that the Management System of: STEELDEC S.A. Valparaiso 4100 Parque Ind. Tortuguitas, (1667) Buenos Aires, Argentina. has been found to conform to the standard: ISO 13485:2003 This Certificate is valid for the following product or service ranges: Design, development, production and sales of sterile and non sterile dental implants, prosthetic components and instruments for dental use. Initial Certification date: 17 October 2012 This Certificate is valid until: 17 October 2015 Place and date: Høvik, 17 October 2012 for the Accredited Unit: DET NORSKE VERITAS CERTIFICATION AS, NORWAY The audit has been performed under the supervision of Paula Tartaglia Lead Auditor MSYS 002 Eugenie Winger Husebye Management Representative Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. This Certificate has been digitally signed. See for more info HEAD OFFICE. Det Norske Veritas AS, Veritasveien 1, 1322 Hovik, Norway. Tel: Fax:

3 DNV BUSINESS ASSURANCE EC CERTIFICATE - FULL QUALITY ASSURANCE SYSTEM Certificate No CE-ARG-NA This Certificate consists of 3 pages This is to certify that the Quality Management System of STEELDEC S.A VALPARAISO 4100 Parque Ind. Tortuguitas, (1667), Buenos Aires, Argentina. for design, production and final product inspection/testing of Dental Devices has been assessed with respect to the conformity assessment procedure described in Article 11.3.a and Annex II exclusive section 4 (Module H) of Council Directive 93/42/EEC on Medical Devices, as amended, and found to comply Further details are given overleaf Place and date: Høvik, 22 Mai 2013 This Certificate is valid until: 22 Mai 2018 For DET NORSKE VERITAS CERTIFICATION AS NORWAY Eugenie Winger Husebye Certification Manager Notified Body No.: 0434 Mitra Salim Technical Reviewer This Certificate has been digitally signed. See for more info Notice: The certificate is subject to terms and conditions overleaf. Any significant changes in design or construction may render this certificate invalid. If any person suffers loss or damage which is proved to have been caused by any negligent act or omission of Det Norske Veritas, then Det Norske Veritas shall pay compensation to such person for his proved direct loss or damage. However, the compensation shall not exceed an amount equal to ten times the fee charged for the service in question, provided that the maximum compensation shall never exceed USD In this provision Det Norske Veritas shall mean the Foundation Det Norske Veritas as well as all its subsidiaries, directors, officers, employees, agents and any other acting on behalf of Det Norske Veritas. Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: Fax: Page 1 of 3

4 Cert. No.: CE-ARG-NA Rev. No.: Project No.: PRJC MSL-ARG Jurisdiction Application of Council Directive 93/42/EEC of 14 June 1993, adopted as Forskrift for Medisinsk Utstyr by the Norwegian Ministry of Health and Care Services. Certificate history Revision Description Issue Date 0 Original certificate Products covered by this Certificate Product Description Product Class Dental Implants External connection implant/she Internal connection implant/shi Class IIb Internal connection tri-channel/sri Prosthetic Abutments Plastic castle abutments, metallic base plastic castle abutment, anatomical titanium abutment, rotational abutment, Titanium abutment with double screw, angulated mini abutment, impression transfer, titanium temporary abutment, analog, healing abutment, straight titanium abutment, fixture mount For SHE/SHI and SRI Models Class IIa The complete list of devices is filed with the Notified Body. Sites covered by this certificate Site Name STEELDEC S.A Address VALPARAISO 4100 Parque Ind. Tortuguitas,(1667),Buenos Aires, Argentina EU Representative SUMINISTROS GALENO SL, Zaire 10 bajo, Perillo, Oleiros, A Coruña, España Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: Fax: Page 2 of 3

5 Cert. No.: CE-ARG-NA Rev. No.: Project No.: PRJC MSL-ARG Terms and conditions The certificate is subject to the following terms and conditions: Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a defect in his product(s), in accordance with directive 85/374/EEC, as amended, concerning liability of defective products. The certificate is only valid for the products and/or manufacturing premises listed above. The Manufacturer shall fulfil the obligations arising out of the quality system as approved and uphold it so that it remains adequate and efficient. The Manufacturer shall inform the local DNV Office of any intended updating of the quality system and DNV will assess the changes and decide if the certificate remains valid. Periodical audits will be held, in order to verify that the Manufacturer maintains and applies the quality system DNV reserves the right, on a spot basis or based on suspicion, to pay unannounced visits. The following may render this Certificate invalid: Changes in the quality system affecting production. Periodical audits not held within the allowed time window. Conformity declaration and marking of product When meeting with the terms and conditions above, the producer may draw up an EC declaration of conformity and legally affix the CE mark followed by the Notified Body identification number of DNV. END OF CERTIFICATE Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: Fax: Page 3 of 3

6 DNV BUSINESS ASSURANCE PRODUCTION QUALITY MANAGEMENT CERTIFICATE Certificate No CE-ARG-NA rev.0.0 This Certificate consists of 3 pages This is to certify that the Quality Management System of STEELDEC S.A VALPARAISO 4100 Parque Ind. Tortuguitas, (1667), Buenos Aires, Argentina. for production and final product inspection/testing of Dental Devices has, on a voluntary basis, been assessed with respect to the CAM D conformity assessment procedure, including the requirements for documentation specified in Annex VII, section 3 of Council Directive 93/42/EEC on Medical Devices, as amended, and found to comply Further details are given overleaf Place and date: Høvik, 22 Mai 2013 This Certificate is valid until: 22 Mai 2018 For DET NORSKE VERITAS CERTIFICATION AS NORWAY Prod002 Eugenie Winger Husebye Certification Manager Mitra Salim Technical Reviewer Notice: The certificate is subject to terms and conditions overleaf. Any significant changes in design or construction may render this certificate invalid. This Certificate has been digitally signed. See for more info If any person suffers loss or damage which is proved to have been caused by any negligent act or omission of Det Norske Veritas, then Det Norske Veritas shall pay compensation to such person for his proved direct loss or damage. However, the compensation shall not exceed an amount equal to ten times the fee charged for the service in question, provided that the maximum compensation shall never exceed USD In this provision Det Norske Veritas shall mean the Foundation Det Norske Veritas as well as all its subsidiaries, directors, officers, employees, agents and any other acting on behalf of Det Norske Veritas. Det Norske Veritas AS, Veritasveien 1, 1322 H øvik, Norway. Tel: Fax: Page 1 of 3

7 Cert. No.: CE-ARG-NA Rev. No.: Project No.: PRJC MSL-ARG Certificate history Revision Description Issue Date 0 Original certificate Products covered by this Certificate Product Description Product name and type designation Class Surgical and prosthetic instruments & kits Instruments: Drill, trephine, countersink, ratchet wrench, torque wrench, hand wrench, drivers, implant depth instrument, fixture mount drivers, osteotome, bone expander, bone tap, handle prosthetic holder. Kits: Multibrand prosthetic kit, surgical kit, osteotomes and expander kit, organizer kit, starter kit. Class I The complete list of devices is filed with the Notified Body. Sites covered by this certificate STEELDEC S.A VALPARAISO 4100 Parque Ind. Tortuguitas,(1667),Buenos Aires, Argentina EU Representative SUMINISTROS GALENO SL, Zaire 10 bajo, Perillo, Oleiros, A Coruña, España Det Norske Veritas AS, Veritasveien 1, 1322 H øvik, Norway. Tel: Fax: Page 2 of 3

8 Cert. No.: CE-ARG-NA Rev. No.: Project No.: PRJC MSL-ARG Terms and conditions The certificate is subject to the following terms and conditions: Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a defect in his product(s), in accordance with directive 85/374/EEC, as amended, concerning liability of defective products. The certificate is only valid for the products and/or manufacturing premises listed above. The Manufacturer shall fulfil the obligations arising out of the quality system as approved and uphold it so that it remains adequate and efficient. The Manufacturer shall inform the local DNV Office of any intended updating of the quality system and DNV will assess the changes and decide if the certificate remains valid. Periodical audits will be held, in order to verify that the Manufacturer maintains and applies the quality system DNV reserves the right, on a spot basis or based on suspicion, to pay unannounced visits. The following may render this Certificate invalid: Changes in the quality system affecting production. Periodical audits not held within the allowed time window. Declaration and marking of product This Certificate and the related assessment activities are intended to increase the confidence of the manufacturer and other stakeholders that the requirements of the stated scheme are met. It is still the full responsibility of the manufacturer to make sure that every product under this Certificate complies with the scheme, and to draw up an EC declaration of conformity and affix the CE mark. END OF CERTIFICATE Det Norske Veritas AS, Veritasveien 1, 1322 H øvik, Norway. Tel: Fax: Page 3 of 3

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