Companies that establish and implement ISO 13485 Medical Devices Quality Management System in their enterprises will always be one step ahead of their competitors if they have obtained ISO 13485 Certificate. This document will give the company prestige and prestige. Which companies can get ISO 13485 Certificate? Before answering this question, the scope of the term medical device, which forms the basis of the standard, should be examined. What is meant by medical devices?

Products that meet the following conditions are called medical devices:

•      It should be used against diseases. Medical devices are used to diagnose, prevent, treat, monitor the course of the disease and reduce the effects.

•      Should be used against injuries. Medical devices are used for diagnosing, treating, relieving the pain and pain of wounds, following the course of the injury and facilitating the daily life of the injured.

•      Medical devices are used to meet human anatomical needs.

•      Medical devices are the devices that replace the anatomical structures of human beings, provide the development of the anatomical structures and support the anatomical structures.

•      Medical devices are the devices that provide continuity of physiological functions of human beings, which can replace physiological functions, provide development of these functions and support physiological functions.

•      Devices that provide life support to people are medical devices.

•      Medical devices are used to monitor the pregnancy processes of women.

•      Medical devices are the devices that allow the examination of the parts taken from the human body.

In another aspect, these medical devices include: vehicles, machines, applications, software, regulators, implanted materials, materials and apparatus. Products with pharmacological (pharmaceutical science), immunological (immune system) or metabolic consequences are not considered medical devices. However, these products may be used as adjuncts with medical devices.

Medical Devices Regulation issued by the Ministry of Health in 2007 also defines medical devices as follows: Medical devices are those devices that do not fulfill their basic duties with pharmacological, immunological or metabolic effects when used on human beings, but which can be supported by these effects when performing their duties. Medical devices may be used in humans for the following purposes:

  • Diagnosis, prevention, monitoring, treatment or mitigation of the disease
  • Diagnosis, follow-up, treatment, reduction of effects or victimization of injury or disability
  • Investigation, alteration or replacement of an anatomical or physiological function
  • Contraception or medication only

These medical devices may be used alone or in combination. It can also be used with computer software if necessary.

Companies that produce and service all medical devices used in similar fields, including but not limited to the above, may establish ISO 13485 Medical Devices Quality Management System in their enterprises and ISO 13485 Certificate They can get.

 

our company TÜRCERT Technical Control and Certification The company provides fast, high quality and reliable consultancy services to all medical device manufacturers who want to establish ISO 13485 Medical Devices Quality Management System and have ISO 13485 Certificate in their companies. ISO 13485 Medical Devices Quality Management System If there is any doubt about who can get the Certificate, we are always with you as a company.