Quality and Certifications

Certifications

The key factors that enable us to produce reliable, high-performance products.

  • Continuous research and development
  • Meticulous attention to detail
  • Patented designs
  • Guaranteed and certified raw materials
  • Strict quality controls during production
  • 100% Made in Italy craftsmanship
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    ADVAN

    Advan’s Certified Quality

    Our quality certifications ensure the safety and reliability of all Advan products while upholding the highest quality standards across every stage of design, development, production, and marketing.

    EN ISO 13485:2016 CertificationWe are a certified company under the international standard EN ISO 13485:2016, operating in compliance with Legislative Decree No. 46 of February 24, 1997 (implementing the European Directive EU MDD No. 93/42/EEC) and Regulation 745/2017.
    Download Certified to EN ISO 13485:2016

    Notified and Certification Body TÜV SÜD P.S. GmbH

    The certification of our quality management system in the medical field guarantees that the organization provides products and services compliant with current laws and regulations. This is achieved through the application of proven, monitored, and continuously improved organizational models.All medical devices placed on the market carry CE marking, ensuring compliance with all requirements of Directive 93/42/EEC and Regulation 745/2017, including aspects such as safety, material selection, and biocompatibility.The company also has extensive experience in registering its products in non-European markets. This process, often time-intensive, is a mandatory step before the devices can be marketed.

    Dowload the Certification

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