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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Recent standards and regulatory activity overview Medical device software Following the failure of the DIS of 62304 to be approved, the IEC 62304 working group requested input from the ISO and IEC member countries. There was not a consensus...
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Questionnaire asking the national bodies to choose which approach to risk management should be used in the second edition of IEC 62304: Standards Navigator 62304 Ed2 Questionnaire
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A presentation on IEC 62304 Second Edition may be found at the following link: Standards Navigator 62304 Ed2 Presentation
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This update addresses International and US National medical device standards ("a view of the landscape") being developed or revised that may be of interest to developers of software for medical devices or healthcare. Some of these standards are used directly for regulatory purposes and others may be valuable in demonstrating to regulatory authorities that a...
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This document is the result of an industry-led initiative of the European Commission. It is targeted at app developers and its purpose is to foster justified trust among users of mHealth apps which process personal data. Standards Navigator Draft Health Code of Conduct
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The document at the link provided is a brochure describing the Standards Navigator subscription options. Subscribing keeps you abreast of Heath IT and Medical Device software standards development, interpretation, and application. Standards Navigator Benefits  
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