H&H Medical Corporation Achieves ISO 13485 Quality System Certification for Medical Device Design, Manufacture and Assembly

Share Article

H&H Medical Corporation (H&H Medical, http://www.gohandh.com/), a leading provider of emergency trauma products and point-of-injury convenience kits, announces it has been successfully certified according to ISO 13485:2003, the international standard for quality management systems for medical device manufacturing.

Achievement of this ISO 13485 certification demonstrates this commitment to quality to our customers in the emergency trauma product market.

H&H Medical Corporation (H&H Medical, http://www.gohandh.com/), a leading provider of emergency trauma products and point-of-injury convenience kits headquartered in Ordinary, Virginia, today announced it has been successfully certified according to ISO 13485:2003, the international standard for quality management systems for medical device manufacturing.

H&H Medical was awarded certification by Eagle Registrations Inc., one of the world's leading certification bodies offering the latest in management systems certification services.

"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 (http://www.ceruleanllc.com). Cerulean specializes in helping firms simplify and streamline FDA and ISO compliance. “Without the assistance and expertise of Mr. Avellanet, this achievement would not have been possible,” said Mr. Harder.

About ISO 13485: ISO 13485:2003 is an international, 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.

About H&H Medical Corporation: H&H Medical Corporation is a world-class provider of point-of-injury trauma solutions for military and civilian customers. H&H Medical’s products have been proven to be life-saving in harsh conditions such as active combat and emergency response situations. 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. For additional information, please visit our website at http://www.gohandh.com.

Share article on socal media or email:

View article via:

Pdf Print

Contact Author

Paul Harder
Visit website