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The Company / Quality

Einco Biomaterial Quality Management System

Ever since it was founded, Einco Biomaterial has continuously invested in the excellence of its products and processes. The Einco Biomaterial Quality Management System (SGG-Einco), which has been implemented at all levels of the organization, guarantees the quality of its products and processes. At the present time, SGQ-Einco has been certified as complying with the following brazilian and international standards:

  • ANVISA RDC 16:2013 => Resolution of the Board of Directors of the brazilian Agency of National Health Surveillance (ANVISA). This establishes the Good Manufacturing Practice and Control requirements for companies that manufacture medical products and is valid all through the Mercosur.

  • EN ISO 9001:2008 and EN ISO 13485:2012 => EincoBio’s Quality Management System is certified .
  • MARK CE => OSTEOSYNT is certified according to the Directive 93/94 of the European Community - Mark CE - enabling it to be comercialized in the countries where this certification is required.

  • MAF/FDA #1677

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