The importance of an ISO 13485 Certification

The importance of an ISO 13485 Certification (Medical Devices).

The ISO 13485 standard establishes the requirements for the quality management system of organizations that manufacture or provide services related to medical devices, and some of them are:

  • Application of a risk management approach to product development.
  • Validation of production processes and service provision.
  • Compliance with regulatory and statutory requirements.
  • Establishment of effective product tracking and recall methods.
  • Monitoring and control of the conditions of the work environment.
  • Design and development of medical devices.
  • Purchases of raw materials and components controlled from a health approach.
  • After-sales service activities.
  • Control of monitoring and measurement devices.
  • Manuals, procedures, instructions and formats for the quality management system.

All products and equipment manufactured by Arigmed go through this entire quality management process, which demands investment of time and resources only for the validation and verification of manufacturing processes and procedures.

Therefore, when you require equipment associated with the treatment of patients such as Medical Gases, look for manufacturers with those certifications.

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