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ISO 13485 QUALITY MANAGEMENT SYSTEM FOR MEDICAL / MEDICAL DEVICES

Medical devices and medical treatment, testing, analysis, service etc. in accordance with the regulations of MDR (Medical Device Regulation) and IVD ISO 13485 Medical / Medical Devices Quality Management System certificate is required for activities. It is emphasized that Medical / Medical device manufacturers who are required to bear CE (European conformity) mark in terms of medical device product safety must first obtain ISO 13485 Medical / Medical Devices Quality Management System certificate:
ISO 13485 Medical devices - Quality management systems Standard is an international standard that has been created on the basis of ISO 9001 Standard and includes special requirements for medical devices. This standard covers the quality management system requirements for an organization that must demonstrate its ability to provide medical devices and consistently meet customer needs and regulatory requirements applicable to medical device-related services. The main purpose of this standard is to facilitate harmonized medical device regulatory requirements for quality management systems. (For an organization to grow and survive successfully, systematic, transparent and business processes need to be traceable and controlled.)

Quality System services for Medical Device Manufacturers

  • General analysis of the current situation,
  • Determining the Project Manager and Team,
  • Determination and definition of processes,
  • Determination and definition of acceptance criteria,
  • Determination of Critical Control Points,
  • ISO 13485 Standard training,
  • Document review,
  • Reviewing pre-audit preparations,
  • Internal auditor / auditor training.

In addition to fulfilling legal requirements, medical device manufacturers who want to gain competitive advantage must prove that they comply with the requirements of the quality management system.
First of all, medical device manufacturers feel the need to establish and certify a Medical / Medical Device Quality Management System in order to meet the current legal requirements, to meet customer needs and expectations, to increase internal efficiency and to create assurance by taking protective measures against risks that may occur. Medical device manufacturers need to overcome many legal barriers to be able to carry out marketing activities in many countries of the world, especially in the European Union and North America. The most important of these is the requirement to have a ISO 13485 Medical / Medical Devices Quality Management System certificate.

Benefits of ISO 13485;

  • The activities of the organization are systematically monitored,
  • It has the opportunity to detect and correct the defective aspects of the system,
  • Increases customer satisfaction,
  • Ensures the continuity of the current system's efficiency,
  • Demonstrates compliance with current legal requirements,
  • It gains advantage to hit the CE mark on its products,
  • It expands its customer portfolio by documenting that it works in accordance with an internationally recognized standard,
  • Thanks to effective application, it decreases customer complaints and product errors,
  • Gains the trust of the interested parties
  • It is prepared against risks and opportunities and inconveniences that may occur.

The way to be followed in the establishment of 13485 Quality Management System;

  • Getting Standard Training,
  • Determination of Working Team and Strategies,
  • Creating a Quality Handbook,
  • Establishing Support Procedures,
  • System Application,
  • Application for Certification,
  • Certification Control.

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