ISO 13485 Medical Devices – Quality Management Systems

ISO 13485 Standard quality system certification is a step for medical device manufacturers to use the CE mark on their products. In the process of compliance with the European Union, all medical device manufacturers aim to establish and certify a quality system to meet current legal obligations, meet customer expectations, increase their efficiency and create a legal assurance. Thanks to some basic features of ISO 13485, such as risk management and record control, it integrates the requirements into management systems that will enable organizations to easily defend themselves in compensation lawsuits.

In organizations applying ISO 13485 Medical Devices – Quality Management System;

  • Meeting the demands of consumers regarding medical device safety,
  • Reducing of waste / scrap amount and returns in production,
  • Minimizing the problems that may be encountered in the audits of organizations that have the legal right to audit,
  • Increasing profit and productivity,
  • Raising awareness of employees about hygiene and sanitation,
  • Increasing in customer satisfaction,
  • Establishing the necessary infrastructure to put the CE mark on the products,
  • Organizations can benefit from the commercial advantages of an internationally recognized quality certificate,

is intended to be provided.

ISO 13485 Medical Devices – Quality Management System Standard audits are conducted in two stages in accordance with the certification process of our national and international representations. The first stage focuses on audit planning and assesses whether the organization is ready for the audit. In the second stage, how the Medical Devices – Quality Management System is established and implemented is audited.

As USB Certification; We carry out ISO 13485 Medical Devices – Quality Management System pieces of training and audits with our expert trainer and auditor staff.

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