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However, BMETs do specialize and focus on specific kinds of medical devices and technology management—(i.e., an imaging repair specialist, laboratory equipment specialist, healthcare technology manager) and works strictly on medical imaging and/or medical laboratory equipment as well as supervises and/or manages HTM departments.
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 ...
This requires that a quality system shall be in place for all the relevant entities and processes that may impact safety and effectiveness over the whole medical device lifecycle. The medical device engineering area is among the most heavily regulated fields of engineering, and practicing biomedical engineers must routinely consult and ...
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.
Retrieved from "https://en.wikipedia.org/w/index.php?title=Medical_device_manufacturing&oldid=889359305"
Teleflex Incorporated, headquartered in Wayne, Pennsylvania, is an American provider of specialty medical devices for a range of procedures in critical care and surgery.. Teleflex has annual revenues of $2.4 billion, operations in 40 countries, and more than 15,000 employe