Cypris Medical Inc announces that an extensive independent audit of its quality management system has successfully culminated in an ISO 13485 certification.
A globally recognized endorsement of standards specific to the medical device industry, ISO certification demonstrates Cypris Medical’s commitment to the highest level of quality, regulatory, and safety controls.
“I’m incredibly proud that our pursuit of exceptional product safety and quality resulted in the certification of Cypris Medical’s system for design, development and manufacturing of medical devices,” says Dan Holton, Chief Executive Officer, in a media release.
“ISO certification marks another significant milestone for us as we advance Xact device commercialization,” he adds. “Cypris Medical’s early achievements include ISO-13485 certification, FDA clearance and more than 100 patient procedures using our novel patented technology. It’s clear why we are excited about the journey ahead. We are opening an entirely new door to minimally invasive plastic surgery.”
The initial iteration of Cypris Medical’s technology, the Xact device, is a handheld surgical suturing tool designed to approximate and pass suture through soft tissue. Facial plastic surgery procedures that incorporate Xact are suitable to be performed without general anesthesia in outpatient settings in less than an hour. Patients typically recover in 5 days or less. Alternatively, traditional facelift, browlift and necklift surgical treatments require general anesthesia and significantly longer recovery times.
John Speer, VP of Quality Assurance at Greenlight Guru, a quality management software provider for the medical device industry, commends Holton and his team, in the release.
“Achieving ISO certification is a huge accomplishment for any medical device company. Cypris Medical clearly embraced the importance of dependable quality from day one. As a result, it has been able to rapidly and efficiently design, develop and manufacture the highest-quality medical devices possible and breeze through the ISO certification process.”
[Source(s): Cypris Medical, Business Wire]