Resonetics Receives Critical ISO-13485 Quality Certification
September 15, 2010 || RESONETICS || RECENT NEWS
Resonetics LLC is proud to announce that it has received ISO 13485:2003 and ISO 9001:2008 quality certifications from the British Standards Institution (BSI)
The Nashua NH-based laser micromachining company received the ISO-13485:2003 and ISO 9001:2008 certifications for micromachining and assembly of medical components and controlled environment assembly. These quality certifications are globally recognized quality management system standards that are essential for organizations to demonstrate the ability to provide medical devices and related services that consistently meet both customer and regulatory requirements.
Resonetics is a laser micromachining company focused on contract manufacturing services to the medical device community. The company obtained the certifications to support its increased focus on the manufacturing of complete medical devices and sub-assemblies, leveraging its core capability of laser micromachining polymer-based devices such as balloons, catheters and diagnostic components.
According to Cliff Gabay, President of Resonetics, “This is an exciting time for us. The award of these certifications is an important milestone in Resonetics strategy to offer more services and capabilities to our existing medical customers. Our medical customers are demanding Resonetics to offer turn-key solutions as they recognize Resonetics can help them lower costs with higher performance and yields. We are committed to satisfying the needs of our expanding medical customer base. There are other forward-thinking corporative initiatives that Resonetics is implementing and we will announce them in the coming months.”