iTech Medical, a medical information technology company, has received ISO 13485:2003 certification for the production and sale of surface electromyography (sEMG) diagnostic devices for clinical use.
The ISO 13485:2003 quality standard is recognised as the international standard for quality management systems specific to the design, development and production of medical devices.
iTech Medical president and CEO Wayne Cockburn said that they are very pleased to have received this international certification of quality standards.
Regulatory authorities in most major markets including the European Union, the US and Canada require, or strongly prefer, that manufacturers selling medical products in their countries have a third-party audited and certified quality management system in place.
“The EU and North America represent the initial target markets for our MPR System and we believe an ISO 13485-compliant system will expedite access into these regions,” Cockburn said.