The ISO 13485 standard defines the structure of the quality system applied to medical device manufacturers.

This milestone marks the first certification of our site under this internationally recognized standard, awarded by a highly regarded and demanding notified body.

With this certification, valid for three years, it enables our customers to speed up the submission of their applications to notified organization. This reinforces our customers’ confidence in our quality system.

Thanks to our team and partners for making this achievement possible!

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