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The latest revision of ISO 13485 for ISO medical devices is from March 2016. Among the additions to this update are included: a focus on risk, clarification of management responsibilities, clarification of training responsibilities, improvement to the facility requirements, better alignment of design a...
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ISO 9000 has its roots in the BS 5750, a standard developed by the British Standards Institution. It was published in 1979 and is considered to be the first management systems quality standard. The BS 5750 replaced specific industry standards and provided a series of standards for all industries...
Unmet healthcare need is a critical indicator, showing a plausible picture of how the healthcare system works in the unprecedented pandemic situation. It is important to understand what factors affect healthcare services of older adults in the midst of the outbreak, as this could help identify se...
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Collaborating with a certified translation and localization provider, especially one with expertise in medical language services and ISO registration, is crucial to navigate the complex international regulatory landscape. Choosing the right translation provider ensures accuracy, consistency, and technical correct...
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Admins can use immutable storage to create an immutable backup for critical data needed for recovery. Immutable storage is for more than just backups, though. Here is how they differ: Immutable backupis a secure data copy that can't be altered or deleted. It's an unchanged copy...