| http://www.w3.org/ns/prov#value | - In contrast to this, standards such as ISO 14971, IEC 62304 and regulatory bodies such as the FDA and the EU, emphasize a 'top-down' approach, such as Hazard Analysis, to ensure that safety and effectiveness are considered from the perspective of the device's intended use rather than just how it functions.Both approaches contribute to the overall safety, effectiveness and quality of a device, and
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