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A safety case aims to show that specific safety claims are substantiated and, in the UK, that risks are kept 'As Low As Reasonably Practicable' ().In the US, the FDA issued a guidance document in 2010 to require infusion pump manufacturers to submit safety cases as part of the 510(k)s.
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With the guidance, a safety assurance case is expected for safety critical devices (e.g. infusion devices) as part of the pre-market clearance submission, e.g. 510(k). In 2013, the FDA introduced another draft guidance expecting medical device manufacturers to submit cybersecurity risk analysis information.
This term has been enshrined in the UK case law since the case of Edwards v. National Coal Board in 1949. The ruling was that the risk must be significant in relation to the sacrifice (in terms of money, time or trouble) required to avert it: risks must be averted unless there is a gross disproportion between the costs and benefits of doing so.
In collaboration with NIOSH, the Specialty: Road Safety at Work branch was added to provide materials related to the prevention of road traffic injuries and deaths while at work. The resources include employer policies and guidance documents on road safety at work, research reports on risk factors for work-related crashes, as well as statistics ...
Certification is achieved by proving the functional safety capability (FSC) of the organization, usually by assessment of its functional safety management (FSM) program, and the assessment of the design and life-cycle activities of the product to be certified, which is conducted based on specifications, design documents, test specifications and ...