ISO 13485, Quality management systems for medical device businesses

Companies who manufactures, develops and/or distributes medical devices must work systematically to ensure the quality of their products and to ensure patient safety. For Class I manufacturers/distributors, a third party certification is not necessary, but nevertheless, a systematic approach to the process of quality assurance must be implemented.

The ISO 13485 standard has been designed to meet the requirements of the European Medical Device Directive, and therefore it is also the path to follow to ensure compliance with the directive - ISO 13485 is a so called harmonized standard.

In our experience, it is not worth the effort to try and find your own ways through the system since the ISO 13485 is so closely tied to the requirements of the directive. This does not mean that all companies need to certify their business according to ISO 13485 or implement a full-scale management system; each business has their specific needs depending on products and format. However, the implementation of ISO 13485 as a basis for the activities performed is wise and constitutes a good basis.

At Symbioteq, we have worked with the ISO 13485 standard since it was published, and we are also part of the technical committee who develops it for the future. We have the practical knowledge needed to implement the standard without it becoming a paper tiger. Contact us and we will explain how a proper management system will benefit your business!