ProTip achieves ISO 13485 and obtains CE mark for intra-laryngeal implant

4 July 2011

Strasbourg-based ProTip SA has achieved ISO 13485 certification, a quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU).

ProTip has also obtained the CE mark for its intra-laryngeal implant, ‘NewBreez’, confirming that it conforms to EU regulations for medical devices.

Obtaining these approvals opens the way for ProTip to begin manufacturing and selling activities.

"ISO 13485 Certification confirms that our manufacturing and quality systems meet the high required standards of medical device companies,” said Maurice Bérenger, CEO of ProTip. “Our employees have shown a great deal of cross-functional diligence and hard work in obtaining this certificate. The reward is that it allows us to expand internationally and to start serving ENT patients across Europe.”