Belgelerimiz


  • ISO 9001:2008 CERTIFICATE

    ISO 9001:2008 Certificate

    ISO - International Organization for Standardization ISO 9001:2008 specifies requirements for a quality management system; ISO 9001:2008 certification has been in place for over a decade now and is used by both customers and companies as a method of controlling quality. ISO 9001: 2008 standards is best practice methodology.

    Pdf Görüntüle (PDF, 8 kB)    


  • ISO 13485 CERTIFICATE

    ISO 13485 Certificate

    ISO 13485 2003 is quality management standard for medical devices.The ISO 13485 standard, officially named EN ISO 13485:2003, can be used by organizations in the design, development and production process for medical devices but also related services. 

    Pdf Görüntüle (PDF, 7 kB)    


  • CE 2292 CERTIFICATE

    CE 2292 Certificate

    CE European Conformity Standards, full quality assurance for medical devices. MDD 93/42/EEC + 2007/47/EC Medical Devices Directive - Annex II, Class IIb, Sterile, Rules 8

    Pdf Görüntüle (PDF, 1 kB)    


  • GS1 GLOBAL STANDARDS CERTIFICATION

    GS1 Global Standards Certification

    GS1, Global Standards is a neutral, not-for-profit, international organization that develops and maintains standards for supply and demand chains across multiple sectors. With local Member Organizations in over 110 countries, GS1 works with communities of trading partners, industry organizations, governments and technology providers and responds to their business needs through the adoption and implementation of global standards.

    Pdf Görüntüle (PDF, 3 kB)    


  • PERFORMANCE TEST CERTIFICATE

    Performance Test Certificate

    Cleenroom Facilities Certifitation Of Performance ISO14644; This part of ISO 14644 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7

    Pdf Görüntüle (PDF, 1 kB)    


  • CERTIFICATE OF IRRADIATION

    Certificate of Irradiation

    Gamma Sterilization Certificate

     After packaging process under the high sterilisation (Sterilization by Gamma Irradiation) , Mode Dental Implant are sterilised with 25 kGy gamma irradiation process and at the final process, packages are stored in the Validation Certified CLEAN ROOM.

    Pdf Görüntüle (PDF, 1 kB)    


  • STABILITY & STERILITY REPORT

    Stability & Sterility Report

    STERILIZATION & 5 YEARS SHELF 

    After Gamma Irradiation process, Mode Implants are 100% sterilized and will remain their sterilization as the first day during the 5 years shelf life. 

    Pdf Görüntüle (PDF, 1 kB)    


  • TITANIUM PRODUCT CERTIFICATION

    Titanium Product Certification

    DYNAMET CARPENTER TITANIUM TiCP4 - Product Certification

    Mode Implant products made from high quality titanium raw material that are supplied from global titanium manufacturer CARPENTER DYNAMET (USA)

    Pdf Görüntüle (PDF, 1 kB)    


  • TORQUE WRENCH PATENT

    Torque Wrench Patent

    Design Patent of torque wrench, in particular for use in surgery and prosthetics. Special alloy titaniyum and TiN coated dental implant ratchet wrench.

    Pdf Görüntüle (PDF, 7 kB)    


  • TURKISH MEDICAL DEVICES REGISTRATION

    Turkish Medical Devices Registration

    TITUBB Documents Registration Notification - REPUBLIC OF TURKEY MINISTRY OF HEALTH 

     Registration application to Republic Of Turkey Medicine and Medical Device National Information Bank (TITUB) institute.

    Pdf Görüntüle (PDF, 2 kB)    


  • TRADEMARK REGISTRATION

    Trademark Registration

    Mode Medikal trademak registration by patent institute

    Pdf Görüntüle (PDF, 1 kB)