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All three forces remain in rigorous, tri-service training for 10 months prior to returning to their individual services. The training is held at Fort Sam Houston and is a part of the Medical Education and Training Campus (METC).The first METC BMET class started on August 4, 2010, and the last Sheppard class graduated on January 14, 2011. [16]
An important aspect of this training is simultaneous, long-term, and detailed exposure to the clinical environment as well as to medical device development activity. [20] This will help students understand how to recognize unmet clinical needs and contribute to the creation of future medical devices.
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 ...
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 risk management stage shall drive the product so that product risks are reduced at an acceptable level with respect to the benefits expected for the patients for the use of the device. The technical file contains all the documentation data and records supporting medical device certification. FDA technical file has similar content although ...
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.