Standard ISO 13485

Quality Management System – Medical Devices

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ISO 13485

The quality assurance of medical devices is vital to ensure compliance with regulatory requirements and requirements of customers. These issues are covered by standard ISO 13485.

ISO 13485:2016 will help you detect critical points and set up and monitor individual processes to ensure the continuous quality of medical devices, including their design, production, assembly and maintenance.

ISO 13485 is recommended to organizations whose activities involve medical devices in any stage of their supply chain.

Requirements of ISO 13485

  • Implementation of extensive requirements for medical facilities.
  • Definition and monitoring of relevant. processes in view of legal requirements
  • Validation of processes.
  • Assuring traceability of products.

Benefits of the Certification 

  • Assuring the necessary quality of medical devices in the entire supply chain. 
  • Improved risk detection and better solutions.
  • Improved competitiveness.
  • Greater trust of your clients. 
  • Compliance with all legal and regulatory requirements.
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The most requested certification

ISO 9001

Quality Management Systems

As the competitiveness of business environment grows, clients demand greater quality of goods and services. Standard ISO 9001 has been developed by International Organization for Standardization (ISO) with the aim to implement the international standardized system for quality management.

ISO 14001

Environmental Management Systems

If you care about the environment, you should seek to adapt your relevant company processes to management systems based on the internationally recognized standard ISO 14001.

ISO 45001

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Occupational safety is an integral part of successful business activities. The internationally recognized standard ISO 45001 aims to improve occupational safety and protection of health at work, while also minimizing the risk of occupational diseases.

ISO 27001

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ISO 22301

Business Continuity Management Systems

ISO 20000

IT Service Management Systems (ITSM)

A successful audit represents the verification of a correctly implemented and well-functioning management system based on ISO 13485. If you want to learn more, please contact us.

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