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The standard IEC 62304:2006 "Medical device software – Software life cycle processes" outlines specific practices to ensure that SOUP components support the safety requirements for the device being developed. In the case where the software components are COTS, DHS best practices for COTS software risk review can be applied. [4]
Every medical treatment facility should have policies and processes on equipment control and asset management. Equipment control and asset management involves the management of medical devices within a facility and may be supported by automated information systems (e.g., enterprise resource planning (ERP) systems are often found in U.S. hospitals, and the U.S. military health system uses an ...
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
In the US, Good Manufacturing Practice (GMP) Regulations are based on the Code of Federal Regulations 21 CFR 210/211, and USP 1079. The US Drug Supply and Chain Security Act (DSCSA), was enacted by Congress on November 26, 2013 and outlines requirements to build electronic systems that identify and trace prescription drugs distributed in the US ...
California created the Medical Waste Management Program, which regulates the generation, handling, storage, treatment, and disposal of medical waste by providing oversight for the implementation of the Medical Waste Management Act. Precautions have been taken in California which permits and inspects all medical waste offsite treatment ...
Chief Executive Magazine gave HDS a ranking of No. 16 in its “40 Best Companies for Leaders” list for 2012. [39] Hitachi Data Systems was recognized among the "Best Companies to Work For" in France [40] and Poland [41] in 2011. In 2010 Hitachi Data Systems was accredited by the Best Companies organization in the United Kingdom. [42]