Standards offer guidance to assist technical writers and editors providing requirements for information products and the process for developing useful documents. Conformance to these standards ensure that the information content, structure and format is consistent across a product documentation set. This makes the documentation easier to develop and more usable. Usability is the “extent to […]
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Safe and Effective Instructions for Use
Safe and Effective Instructions for Use The intent of most device instructions is to provide necessary and useful information in a form that can be easily read and understood. Medical device instructions are intended to provide adequate directions for use such that the device can be used safely and effectively. The responsibility for assessment of […]
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The Service Manual Problem
New Standard for Access to Medical Equipment Service Manuals: My latest blog on the long-running battle over adequate access to service manuals for purchasers of medical devices. Comments on TJC announcement of new elements of performance regarding manuals, procedures, technical bulletins, and other information requirements.
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