03.05.14
H&H Medical Corp., a provider of emergency trauma products and point-of-injury convenience kits has been certified to ISO 13485:2003, the international standard for quality management systems for medical device manufacturing.
The company was awarded certification by Eagle Registrations Inc.
"H&H Medical made significant commitments in the last several years to improve our customer service and quality. Achievement of this ISO 13485 certification demonstrates this commitment to quality to our customers in the emergency trauma product market," said Paul Harder, president of H&H Medical. "This certification reflects the significant investment in the quality systems required to manufacture our unique trauma response products."
H&H Medical was assisted in the achievement of this milestone by the work of John Avellanet of Cerulean Associates LLC. Cerulean specializes in helping firms simplify and streamline ISO and U.S. Food and Drug Administration compliance.
“Without the assistance and expertise of Mr. Avellanet, this achievement would not have been possible,” said Mr. Harder.
ISO 13485 is a globally recognized standard for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical device manufacturing. ISO 13485 is based on quality management principles that have been proven to enhance organization performance.
Based in Ordinary, Va., H&H Medical's products are found in kits and assemblies used by such customers as the U.S. Marine Corps, U.S. Army, Kingdom of Saudi Arabia, U.S. Secret Service, and other military and law enforcement entities.
The company was awarded certification by Eagle Registrations Inc.
"H&H Medical made significant commitments in the last several years to improve our customer service and quality. Achievement of this ISO 13485 certification demonstrates this commitment to quality to our customers in the emergency trauma product market," said Paul Harder, president of H&H Medical. "This certification reflects the significant investment in the quality systems required to manufacture our unique trauma response products."
H&H Medical was assisted in the achievement of this milestone by the work of John Avellanet of Cerulean Associates LLC. Cerulean specializes in helping firms simplify and streamline ISO and U.S. Food and Drug Administration compliance.
“Without the assistance and expertise of Mr. Avellanet, this achievement would not have been possible,” said Mr. Harder.
ISO 13485 is a globally recognized standard for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical device manufacturing. ISO 13485 is based on quality management principles that have been proven to enhance organization performance.
Based in Ordinary, Va., H&H Medical's products are found in kits and assemblies used by such customers as the U.S. Marine Corps, U.S. Army, Kingdom of Saudi Arabia, U.S. Secret Service, and other military and law enforcement entities.