Quality & Regulatory


SYMATESE DEVICE has always set the quality of its products and patient safety as its main target, and has implemented an effective quality system, which meets the most important requirements in terms of quality (ISO 13485 and QSR - 21 CFR part 820).

Our daily goal is to guarantee that patients receive safe, high-quality products meeting regulatory and legal requirements. Every day, in all our activities, we are committed to moving towards excellence and performance.

Our project management system guarantees industrial services that meet international regulatory standards all the way through from concept to product launch (North America, South America, Asia, Europe etc.).



Throughout the medical device development process, regulatory requirements are taken into account.

Our Regulatory Affairs team can advise our customers all the way through from concept to product launch. Knowledge of the regulations worldwide and sales experience on the SYMATESE DEVICE overseas markets is an aid for making the right technical choices.



Certificate NF EN ISO 13485 : Certification of the Quality Management System by our notified body for medical devices LNE (National laboratory of metrology and tests) / GMed

CE Certificate: Approval of full Quality Assurance System

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