Eko, a leading acoustic cardiac monitoring company, received the International Organization for Standardization (ISO) 13485:2016 and Medical Device Single Audit Program (MDSAP) certifications following successful audits of its manufacturing sites and operations. This indicates that Eko continues to follow rigorous quality and regulatory standards for medical manufacturers. Eko products are approved for sale in the U.S., Europe and certain other countries for heart sound and ECG monitoring and screening.
ISO 13485:2016 is the state-of-the-art quality management system standard for medical devices, under which an organization demonstrates its ability to provide medical devices and related services that consistently meet applicable regulatory requirements. ISO is an independent, non-governmental international organization that sets standards for compliance with industry best practices.
MDSAP was established by a coalition of international medical device regulatory authorities, including the U.S. Food and Drug Administration, Australia’s Therapeutic Goods Administration, Health Canada, Japan’s Ministry of Health, Labour and Welfare, and Brazil’s health regulatory agency ANVISA. This program enables a manufacturer to contract with an authorized third-party auditing organization to conduct a single audit to satisfy the relevant regulatory requirements of participating authorities.
MDSAP regulatory certification was received for the company’s sites in Berkeley, California. In addition, ISO 13485:2016 specifically sets a new standard concerning design and development validation, indicating that if a medical device’s intended use requires it to be connected to or interfaced with other products, validation should include confirmation that all necessary requirements have been met when connected or interfaced.