ProTip SAS Achieves ISO 13485 Certification and Obtains CE Mark for its Intra-Laryngeal Implant 'Newbreez'  
6/15/2011 10:28:19 AM

Strasbourg, France, June 15th, 2011 - ProTip SA, a medical device company dedicated to finding innovative solutions for patients suffering from larynx malfunctions, today announced that the company has achieved ISO 13485 Certification. ISO 13485 is an internationally recognized 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). It 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.”

About ProTip SA

ProTip SA is a privately held medical device company dedicated to finding innovative solutions for patients suffering from larynx malfunctions. Its initial focus is to develop a permanent implant for Laryngectomy patients. ProTip, based in Strasbourg, in Eastern France, was founded in 2004 and has since benefited from strong support from the Alsace region and Oseo, the French government innovation agency. The company has won several prestigious awards in France. It has established partnerships with a number of academic establishments and has recently strengthened its ties with the University Hospitals of Strasbourg and with Inserm. A team of experienced managers is in place with the objective of accelerating international company development.

Mark Tidmarsh


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