ISO 13485

ISO 13485 certification for medical component manufacturers

In order to justify the processes involved in the development, production, design, and servicing of medical devices and in vitro diagnostic devices, medical device companies must implement a reliable quality management system.

The international, process-oriented standard ISO 13485 forms the basis for the certification of quality management systems in companies that manufacture or distribute medical devices - or participate in their manufacture as part of the supply chain.

The benefits you get from the ISO 13485 certification

  • Proof of compliance with the relevant guidelines for the manufacture of medical devices

  • Increased efficiency of the company

  • Higher profits at lower risks

  • Fulfillment of all important industry requirements

  • Easier access to new markets

  • Competitive advantages and winning new customers

ISO 13485 Certification

About ISO 13485 certification

An internationally recognized and harmonized quality management system (QMS) standard, ISO 13485 was especially developed for medical device companies. Derived from ISO 9001, ISO 13485 provides guidance and tools to create an effective QMS to ensure product and service quality. The audit plan is aligned with your business goals to help you achieve your individual management objectives. ISO 13485 enables you to certify your system according to the quality system requirements as well as regulatory statues.

Process of ISO 13485 certification

  1. Information and preliminary audit (optional)
    Informative introductory meeting
  2. Documentation review
    Preparation for certification including document review
  3. Certification audit
    Our auditors check your environmental management system on site
  4. Certificate conferral
    After successful certification you will receive our DEKRA test seal
  5. Regular monitoring audits
    Annual monitoring to ensure proper implementation of requirements in practice
  6. Re-certification
    Certification renewal every three years

Gain from our expertise

  • We are one of the five largest Notified Bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices as well as in-vitro diagnostic medical devices.
  • Certification improves the efficiency of your business to increase profits.
  • Our experts have many years of experience in the field of certification of management systems.

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