France-based ProTip, a medical device company that develops solutions for larynx malfunctions, has achieved ISO 13485 Certification.
The company has also obtained the CE mark for its intra-laryngeal implant ‘NewBreez.’
The approvals will allow the company to manufacture and sell across Europe.
ProTip CEO Maurice Berenger said the reward is that it allows them to expand internationally and to start serving ENT patients across Europe.
ProTip said its initial focus is to develop a permanent implant for laryngectomy patients.