3T Medical Complete Achieves ISO 13485:2016 Certification
3T Medical Complete Achieves ISO 13485:2016 Certification
January 20, 2020
Canton, MI, USA
3T Medical Complete Systems (3TM) Inc., a private growth company focused on disposable medical devices for the operating room and infection control, today announced that the Company has received the International Standards Organization (ISO) 13485:2016 certification of its quality management system, an internationally recognized high quality standard for medical devices.
ISO 13485:2016 certification recognizes that consistent quality policies and procedures are in place at 3TM for the design, development and manufacturing of medical devices. Certification to this standard is one of the key regulatory requirements for a CE Mark in the European Union as well as requirements in other international markets.
“We are pleased to have achieved this important milestone for our quality system as we work towards bringing our products to the European market and beyond,” said Jack Kelley, CEO of 3T Medical Complete. “The certification confirms that our quality systems meets a high standard, and signals our commitment to quality to our customers.”
For more information on 3T Medical Complete Systems (3TM) Inc., please visit www.3tmedical.com