ISO 13485

What is ISO 13485?

ISO 13485 is a quality management standard for medical devices and, in practice, a requirement for EU MDR-classified products. Our product Amnicare is currently classified as a medical device according to MDR class IIa. However, our other product Pulstavlan is also being developed with the same quality system, even though it is not formally classified as a medical device today.

ISO 13485 is based on ISO 9001 but is specifically adapted to cover all the requirements needed for a medical device system with a focus on patient safety, covering all aspects of developing, using, and maintaining systems that can affect a patient's well-being. Compared to ISO 9001, ISO 13485 places significantly higher demands on documentation, is risk-based, and also sets requirements for support and incidents, as well as clearer requirements for design, verification, and validation.

ISO 13485 also means that a number of other ISO standards and guidelines need to be implemented – our quality system implements over 40 different standards and guiding documents. Here are some of the major standards we implement:

• ISO 14971: Risk management for medical devices
• ISO 62366-1: Usability for medical devices
• IEC 62304: Lifecycle management for medical device software
• IEC 82304-1: Product safety for health software

Questions?

Feel free to contact us if you have more questions about this – we love to talk about quality systems and standards!