Quality Management System Certification for Medical Devices ISO 13485

Medical devices, may it be hardware or software used in treating human beings or in diagnosis of diseases, have a significant effect on patient safety and risk management in medical business. Quality Management System based on ISO 13485 helps medical device manufacturers in reducing risks and in making better reliability.

ISO 13485 is the most widely used for medical devices throughout the world. Successful design and manufacture of medical devices and supplies entails Quality Management System based on ISO 13485.

The standard ISO 13485:2012 was created specifically for medical devices and supplies and is based on ISO 9001. The standard has been made into a tool for the manufacturer to use in creating preconditions through which to cater for the regulatory safety and performance requirements as well as client requirements at various stages of product life.

The standard does not provide a direct solution to design quality. However it helps to create a framework which enables the use of various solution models depending on the one hand on manufacturer’s size, the complexity of the products and the potential risks and on the other the quality targets set by manufacturers themselves with regard to both their own operations and the devices.


  • Improves risk management and reduces risks
  • Tool to develop management activities
  • Tool to ensure your business’s continuity
  • Tool to involve staff  through risk management
  • Signal of reliability for your stakeholders
  • Improves efficiency