Atrenne (a Celestica company) announced today that was granted ISO 13485:2016 certification for medical device design.
Brockton, Massachusetts-based Atrenne designs, develops and deploys industrial embedded computers. The company said in a news release that garnering ISO 13485 certification expands its capabilities for the design of medical products including components, integrated assemblies and embedded computing platforms.
Atrenne offers custom, integrated components, electronic packaging, fabricated metal, electronic assemblies, and manufacturing services to customers across the world.
“ISO 13485 certification enables us to expand our expertise in systems design to help our global healthcare customers deliver products at the highest levels of quality and demonstrate full regulatory compliance,” Atrenne President and CEO Chris Boutilier said in the release. “We have been serving customers in highly-regulated markets for almost 50 years, and are excited that we can now apply our commitment to quality and rigor to help medical device companies overcome design challenges and meet the high demand for their products.”