ISO 9001 and ISO 13485 are international standards specifying requirements for Quality Management Systems. ISO 9001 is applicable to any kind of organisation. However, the requirements of ISO 13485 are specific to organisations providing medical devices. Application of the standard is not obligatory. However, ISO 13485 certification can greatly facilitate the CE marking process of your medical device.

Because of our experience in the medical devices business, we have a profound understanding of the business processes of medical device companies, varying from design to production to sales. We know how to interpret ISO 13485 to every kind of medical device company and how to establish a Quality Management System that complies with the requirements.

As ISO 13485 follows the format of ISO 9001, we also know how to allign the Quality Management System with the requirements of ISO 9001.