Safe medical devices thanks to ISO 13485

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In the medical device industry, safety and quality are critical. The regulatory requirements for a medical device are therefore very strict and complex at every step of its life cycle. This is why a quality management system for medical devices was developed: ISO 13485.

What is ISO 13485?

Covering everything from plasters, sterile gauze, and dental chairs to pacemakers, implants, heart-lung machines, and beyond, the list of medical devices is very long. And all manufacturers, suppliers and distributors of these products and devices must comply with the international ISO 13485 medical devices standard. In doing so, they demonstrate their compliance with European regulations.

Who is using ISO 13485?

ISO 13485 was developed for organisations that design, manufacture, install and/or maintain medical devices. A medical device is any product used in the diagnosis, prevention and treatment of diseases and medical conditions.

Internal and external parties, such as certification bodies, can also use the standard in their auditing processes.

More about ISO 13485

Want to know more about medical device quality and safety? You can learn all about it on our dedicated webpage.

ISO 13485

Getting started with ISO 13485?

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Other medical device standards

In addition to the ISO 13485 quality management standard, there are many other standards for the medical device industry, such as:

  • ISO 14971, Medical devices – Application of risk management to medical devices
  • ISO 20417, Medical devices – Information to be supplied by the manufacturer
  • ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
  • IEC 62366 series on the application of usability engineering to medical devices

More on medical device standards

Would you like to discover the various standards developed for medical devices? Check out our overview of the most important ones.

Standards for medical devices

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