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This message was posted by a user wishing to remain anonymous Thanks for your responses, however I would assume for a class IIb (non-implantable) , such a contract would not be required?

This message was posted by a user wishing to remain anonymous Wanted to understand the responsibilities and legal obligations of the importer / UKRP/ service and maintenance provider ( all three are assumed by one entity) if there are unauthorized device modifications in the field. From the guide ...

This message was posted by a user wishing to remain anonymous Hello - I am building a Word template to compile information for Traditional 510(k) submissions and facilitate team reviews before moving information over to eSTAR. So far the process of extracting a complete set of fields and questions ...

This message was posted by a user wishing to remain anonymous What exactly needs to be done to export and have approved medical devices in Vietnam? What are the practices, rules and regulations to achieve that? Can you elaborate and provide precise details? It is about class IIb (and below) medical ...

This message was posted by a user wishing to remain anonymous Hello Forum! We are currently having discussion regarding initiation of stability studies and the whether the application of a shelf-life to general medical devices (wound care products, hemostats, gels) can be done based on accelerated ...