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ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
The Personnel Reliability Program (PRP) is a United States Department of Defense security, medical and psychological evaluation program, designed to permit only the most trustworthy individuals to have access to nuclear weapons (NPRP), chemical weapons (CPRP), and biological weapons (BPRP).
The MDA established a risk-based framework for the classification of medical devices and a regulatory pathway for medical devices to get to the market, created a regulatory pathway for medical device clinical trials, and established several post-market requirements including manufacturer registration and device listing with the FDA, good ...
Finally, risk may be managed by influencing the severity of outcomes. For instance, seatbelts and airbags do nothing to prevent bridges from becoming icy, nor do they prevent accidents caused by that ice. However, in the event of an accident, these devices lower the probability of the accident resulting in fatal or serious injuries. [citation ...
A device or system must meet the requirements for both categories to achieve a given SIL. The SIL requirements for hardware safety integrity are based on a probabilistic analysis of the device. In order to achieve a given SIL, the device must meet targets for the maximum probability of dangerous failure and a minimum safe failure fraction.
However, the Marine Corps decided to bring back the older Army Rifle Marksmanship Badges in 1937. That same year, the Marine Corps introduced the Marine Corps Basic Badge for marksmanship qualifications with other weapon systems. Clasps were hung from the Marine Corps Basic Badge's brooch indicating the type of weapon and level of qualification.
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.
Industries regulated in this way include transportation (such as aviation, the automotive industry and railways) and medical devices. As such there are strong parallels with the formal evaluation of risk used to prepare a Risk Assessment, although the result will be case specific. A vehicle safety case may show it to be acceptably safe to be ...