All medical device manufacturers should establish ISO 13485: 2012 Medical Devices Quality Management System in order to ensure compliance with European Union nominations, to act in accordance with the current legal regulations, and to provide quality production and service and thus to create customer satisfaction. and ISO 13485 Certificate must take.

In order to implement the ISO 13485 standard within the company, the risks of medical devices produced and provided with technical support services should be defined and the risk dimensions should be determined. In addition, studies in this direction must be recorded. Risk assessment studies are generally a basic requirement for all management systems.

Risk assessment studies should include the following activities:

  • Description and intended use of medical devices and parts manufactured
  • List of risks arising at the end of the study
  • What steps can be taken to reduce these risks
  • Introducing the unit and the personnel performing the hazard analysis
  • What are the environmental risks that arise during the firm's production activities and their extent
  • Detailed information and comments on the medical device or medical device produced and provided with technical support
  • Identify possible interactions of the medical device with other devices or drugs
  • Electromagnetic or energetic emission status of medical device
  • What is the regular maintenance of the medical device?
  • What is the lifetime of the medical device
  • What are the effects of the medical device due to prolonged use?
  • How many times or for how long the medical device can be used
  • Pre-test results for medical devices
  • Customer satisfaction records

When setting up the ISO 13485 standard, the potential hazards associated with the manufacture of medical devices should also be analyzed. These hazards may include:

  • Whether there is a danger to the energy emitted by the medical device during operation
  • Whether the medical device has the potential to create a chemical hazard
  • Whether the medical device has a biological hazard
  • Whether there is a danger that may arise when using the medical device
  • Whether the medical device poses a danger to the environment
  • What are the hazards that may arise from the use or misuse of the medical device?

Other standards, academic publications, case studies or data obtained in the clinical setting may also be used to analyze the presence of such hazards. Hazard analysis results must also be documented and stored.

 

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