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