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What Is ISO 13485

The ISO 13485 certification stands for meeting the comprehensive requirement for a QMS. Possessing ISO 13485 serves a practical foundation for the manufacturing units and suppliers that they are committed to maintain the safety and quality of medical devices. The ISO 13485 certifications is globally recognized and accepted ISO 9000 quality management standards series. The motto behind developing this certification is supporting medical device manufacturers and suppliers in order to design a quality management system adhered to establish and maintain the effectiveness of their process.

The ISO 13485, the quality management system is dedicated to address the development, regulatory purposes, and implementation. It is originally developed in 1990 and similar to ISO 9001. But ISO 13485 has additional requirements belong to medical devices. This certification ensures the safe process of installation, production, development, and designing. It is required to hold by the manufacturing units to leave the direct impact on their effectiveness including the safety of users and patients. It becomes hard to make a legal entry into the prominent and major markets for the manufacturer and suppliers if they do not hold ISO 13485 certification.


Benefits Of 13485

  •    Holding 13485 lifts up the value of the manufacturer and suppliers into the major markets.
  •    This certification is recognized worldwide and increase access to more market.
  •    Highlight how to review and go through the constant improvement process.
  •    It takes customers in belief that your products are safer and more effective
  •    It meets customer and user  expectations
  •    The ISO 13485 meets regulatory.

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