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Design and development planning; Design input, including intended use and user needs (also known as customer attributes) Design output, including evaluation of conformance to design input requirements through: Design verification confirming that the design output meets the design input requirements ("did we design the device right?")
The Healthcare Sterile Processing Association (HSPA), formerly International Association of Health Central Service Material Management (IAHSCMM), [3] is a professional association which represents healthcare Central Service (CS) professionals, and is based in Chicago, Illinois with over 48,000 [4] members worldwide.
A biomedical engineering/equipment technician/technologist (' BMET ') or biomedical engineering/equipment specialist (BES or BMES) is typically an electro-mechanical technician or technologist who ensures that medical equipment is well-maintained, properly configured, and safely functional.
Equipment used in aseptic processing of food and beverages must be sterilized before processing and remain sterile during processing. [1] When designing aseptic processing equipment there are six basic requirements to consider: the equipment must have the capability of being cleaned thoroughly, it must be able to be sterilized with steam, chemicals, or high-temperature water, sterilization ...
A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organization in the pharma industry, is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive ...
Instrumentation engineering is the science of the measurement and control of process variables within a production or manufacturing area. [1] Meanwhile, control engineering, also called control systems engineering, is the engineering discipline that applies control theory to design systems with desired behaviors.
Sterile dental instruments from hospital central supply (barcoded label indicating sterilization date, expiry date and contents). The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization ...
The Design of Inquiring Systems: Basic Concepts of Systems and Organization. New York: Basic Books. ISBN 0-465-01608-1. Gosling, William (1962). The design of engineering systems. New York: Wiley. Hawryszkiewycz, Igor T. (1994). Introduction to system analysis and design. Prentice Hall PTR. Levin, Mark S. (2015). Modular system design and ...