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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
The 2002 Medical Device User Fee and Modernization Act (MDUFA) first granted FDA the authority to collect user fees from industry to help the FDA improve efficiency, quality, and predictability of medical device submission reviews; the medical device user fee program has been reauthorized several times with the most recent in 2022.
McKesson Corporation is a publicly-traded American company that distributes pharmaceuticals and provides health information technology, medical supplies, and health management tools. The company delivers a third of all pharmaceutical products used or consumed in North America and employs over 80,000 employees.
In addition, medical supply technicians are responsible for maintaining requirements and records on storage/war reserve materiel; establishing stock control levels and inventory control; controlled medical items (i.e. drugs and precious metals); and delivering supplies and equipment to the customers. Medical logistics is often confused with and ...
Medical equipment management (sometimes referred to as clinical engineering, clinical engineering management, clinical technology management, healthcare technology management, biomedical maintenance, biomedical equipment management, and biomedical engineering) is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare ...
Strengthen quality assurance (QA) and quality control (QC) systems; Increase the supply of quality assured medicines; Combat the availability of substandard and counterfeit medicines; Provide technical leadership and global advocacy; USP-USAID collaborative efforts have helped communities improve drug quality in more than 35 countries.