Metal 3D printing company PrinterPrezz (Fremont, Calif.) today announced it has achieved ISO 13485:2016 certification for Quality Management Systems for medical devices.
ISO 13485:2016 certification is a requirement for regulatory purposes and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
PrinterPrezz said it has met these standards for fabrication and 3D printing of titanium, non-titanium metals and advanced resin and plastic non-active implantable and non-implantable medical devices, associated components and surgical tools for the medical device industry.
“Designing and implementing a quality management system and achieving ISO 13485:2016 certification are important milestones for our company that reflect our emphasis on safety and providing high-quality devices,” PrinterPrezz CEO Shri Shetty said in a news release. “I am proud of the collaborative efforts of our team which underscore our commitment to supporting our customers, as together we revolutionize the way advanced medical devices are developed and brought to market.”
PrinterPrezz recently opened an innovation center in Silicon Valley to offer customers medical device digital design services with clinicians, engineers, and materials scientists.
