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We have been successfully audited by the Notified Body TÜV SUD on the ISO 13485. After having CE marked our first product and established the production line, the company has demonstrated to be able to produce batches according to ISO quality standards. 

“We have established a trustful relation with the Notified Body creating a solid ground for future products approval” – Commented Francesca Ceccarelli (Quality and Regulatory Manager of Aesyra).