Brian A Jackson
Heart Test Laboratories, a Texas-based firm which provides screening tools for the early detection of heart disease, has achieved ISO 13485:2003/NS-EN ISO 13485:2012 certification for its quality management systems.
The certification includes activities related to the design and development, manufacturing, distribution and servicing of active non-invasive electrocardiographic devices for screening for a variety of cardiac abnormalities and disease.
ISO 13485 is an International Organization for Standardization (ISO) standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. I
SO 13485 is now considered to be the standard and a requirement for medical devices including Global Harmonization Task Force Guidelines (GHTF). Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.
The US Food and Drug Administration’s (FDA) Quality System Regulation 21CFR Part 820 contains requirements for medical device manufacturers and is harmonized with ISO 13485 in terms of the quality management systems requirements thus allowing a significant amount of the work to benefit towards meeting FDA QMS system requirements.
Mark Hilz, president and chief executive officer, said: “This is a significant step in the process of commercializing the MyoVista technology and demonstrates HTL’s commitment to deliver a high quality product. Our team spent months working diligently to obtain EN ISO 13485 certification.”
Heart Test Laboratories, Heart disease, Early detection, ISO 13485 certification, FDA, Risk management, US
