ISO 13485 - medical devices -CERTIFICATION of quality management systems

ISO 13485: 2016, Medical devices - Quality management system
- is an internationally agreed standard that places demands on a quality management system that is specific to the medical technology industry.
Safety and quality are crucial in this business.

ISO 13485 specifies requirements for a management system where an organization needs to demonstrate its ability to provide medical equipment and associated services that meet customer requirements and regulatory requirements.

ISO 13485 covers all aspects of the production of products and services - from development and marketing to production, maintenance and related services such as sterilization, validation, testing and customer support.

ISO 13485 is easy to combine with other standards such as ISO 9001,
ISO 14001 or ISO 45001 as they have a similar structure.

A3CERT is accredited by SWEDAC to certify against ISO 13485: 2016. Welcome with your quote request or contact us if you have any questions

ISO 13485 - Quality management system for medical devices
To be able to deliver medical technology, stringent requirements are set at all stages of a product's life cycle, from the development, production, storage, distribution, installation and service of these products. The methodology works for all companies regardless of their size.