Standard ISO 13485

Quality Management System – Medical Devices

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ISO 13485

Accredited by: ČIA
Provided by: LL-C (Certification) Czech Republic a.s.

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

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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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ISO 27001

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ISO 22301

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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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