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  • Jim, I would recommend you seriously consider what I am suggesting below. As for a "feature" suggested by a customer, you should analyze as follows. Based on intended use/indications for use (user needs/user requirements), design control starts with development/approval of design inputs (design input requirements). You...

  • The first issue is the context of your question. You start with the context of a class 1 medical device in the EN ISO 13485 environment, but then shift to the definition from FDA. I infer the context is EN ISO 13485:2012. The definition of a complaint and the requirements to handle complaints are not the same in FDA QSR and in ISO 13485:2012....

  • There are some clarifications in order. ISO 14971:2007 has not been updated. The international version remains at the 2007 revision and is among the recognized standards in both the US and Canada. What has changed is EN ISO 14971:2012 which seeks to address discrepancies between the international standard and the EU product directives related...

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