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Renewal of our certification NF EN ISO 13485: 2016

Already ISO 13485 certified since June 2013, FORGINAL medical has obtained the renewal of its certification according to the NF EN ISO 13485:2016 standard for the next 3 years following an external audit carried out by our notified body, the BSI.

By choosing to apply the highest quality standards in the field of medical devices, we prioritize first and foremost, the satisfaction of our customers and partners who are themselves subject to strong regulatory requirements. During this renewal audit, FORGINAL was able to demonstrate its ability to meet the expectations of its customers and give them confidence through the maintenance of an effective quality management system that must mature from year to year.

We invite you to download our new ISO 13485:2016 certificate below.